User:GobsPint/List of CLIA analytes categorized as high complexity by the CDC

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ID Document_Number Test_System_ID Test_System_Name Qualifier1 Qualifier2 Analyte_ID Analyte_Name Specialty_ID Complexity Date_Effective
1 43053 Nichols Institute 1,25-Dihydroxyvitamin D Assay Kit 104 1,25-Dihydroxyvitamin D (1,25-(OH)2D) 2 HIGH July 26, 1993
2 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 107 1-Methylhistidine 2 HIGH November 10, 1994
3 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 107 1-Methylhistidine 2 HIGH May 26, 1995
4 58051 Sigma Diagnostics Test Kit 106 17 Ketosteroid 6 HIGH July 26, 1993
5 13030 Diagnostic Products Corp. Coat-A-Count 102 17 OH Progesterone 6 HIGH July 26, 1993
6 13185 Diagnostic Systems 17alpha-OH Progesterone RIA Kit 102 17 OH Progesterone 6 HIGH July 26, 1993
7 13030 Diagnostic Products Corp. Coat-A-Count 103 17 OH Progesterone, Neonatal 6 HIGH July 26, 1993
8 70157 Wallac Oy DELFIA Neo-17a-OHP Kit 103 17 OH Progesterone, Neonatal 6 HIGH September 1, 1994
9 K973350 8127 Bio-Rad Microplate 17-Hydroxyprogesterone 109 17 alpha-OH Progesterone 6 HIGH September 4, 1998
10 E990024 34101 KMI Diagnostics 17-alpha-Hydroxyprogesteron(e) ELISA 109 17 alpha-OH Progesterone 6 HIGH March 26, 1999
11 K934178 43105 Neometrics ACCUSCREEN 17alpha-hydroxyprogesterone RIA Kit 109 17 alpha-OH Progesterone 6 HIGH April 21, 1995
12 K940233 49124 Pantex NeoScreen ELISA 17 alpha-Hydroxyprogesterone 109 17 alpha-OH Progesterone 6 HIGH January 6, 1995
13 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 108 3-Methylhistidine 2 HIGH November 10, 1994
14 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 108 3-Methylhistidine 2 HIGH May 26, 1995
15 4035 Abbott Bichromatic ABA 100 105 5'Nucleotidase 2 HIGH July 26, 1993
16 4036 Abbott Bichromatic ABA 200 105 5'Nucleotidase 2 HIGH July 26, 1993
28 16010 Electronucleonics FLEXIGEM 105 5'Nucleotidase 2 HIGH July 26, 1993
34 28183 Instrumentation Laboratory Multistat III 105 5'Nucleotidase 2 HIGH July 26, 1993
35 28184 Instrumentation Laboratory Multistat III Plus 105 5'Nucleotidase 2 HIGH July 26, 1993
46 58051 Sigma Diagnostics Test Kit 105 5'Nucleotidase 2 HIGH July 26, 1993
53 K952817 7687 Bio-Rad Urinary 5-HIAA by HPLC 101 5-Hydroxyindolacetic Acid, Urine (5-HIAA) 6 HIGH September 15, 1995
54 4174 Amtec Anti-H Lectin - Saliva (qualitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
55 7008 BCA Anti-H Lectin - Saliva (qualitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
56 7009 BCA Anti-H Lectin - Saliva (quantitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
57 13013 Dade Lectin-H - Saliva (qualitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
58 13014 Dade Lectin-H - Saliva (quantitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
59 22007 Gamma Anti-H Lectin - Saliva (qualitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
60 22008 Gamma Anti-H Lectin - Saliva (quantitative) 401 ABH secretor status - Saliva 5 HIGH July 26, 1993
61 4115 All Immunohematology Absorption/Elution Procedures-Ag confirmation 402 ABO group - RBC 5 HIGH July 26, 1993
72 13113 Dynatech MicroBank System 402 ABO group - RBC 5 HIGH July 26, 1993
77 22029 Gamma STS-M Automated Blood Grouping Instrument 402 ABO group - RBC 5 HIGH July 26, 1993
79 28087 IBG Inverness Blood Grouping System 402 ABO group - RBC 5 HIGH July 26, 1993
85 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 402 ABO group - RBC 5 HIGH July 26, 1993
92 13113 Dynatech MicroBank System 403 ABO group confirmation - Serum, Plasma 5 HIGH July 26, 1993
95 22029 Gamma STS-M Automated Blood Grouping Instrument 403 ABO group confirmation - Serum, Plasma 5 HIGH July 26, 1993
97 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 403 ABO group confirmation - Serum, Plasma 5 HIGH July 26, 1993
101 K960090 55206 Remel Calcofluor White Stain Kit 523 Acanthamoeba 11 HIGH May 17, 1996
106 4275 Ames OPTIMATE 406 Acetaminophen 7 HIGH July 26, 1993
130 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 406 Acetaminophen 7 HIGH July 26, 1993
138 22140 GDS Diagnostics Enzymatic Test Kit 406 Acetaminophen 7 HIGH July 26, 1993
176 58165 Sherwood Medical Rapid Stat Diagnostic Kit 406 Acetaminophen 7 HIGH July 26, 1993
177 58157 Stanbio Test Kit 406 Acetaminophen 7 HIGH July 26, 1993
178 58082 Syva Emit Test Kit 406 Acetaminophen 7 HIGH July 26, 1993
179 58190 Syva Qstat/Qst System 406 Acetaminophen 7 HIGH July 26, 1993
185 7300 Bioanalytical Systems BAS 200A 476 Acetylcholine/choline 7 HIGH July 26, 1993
186 7301 Bioanalytical Systems BAS 480 476 Acetylcholine/choline 7 HIGH July 26, 1993
187 7302 Bioanalytical Systems BAS 481 476 Acetylcholine/choline 7 HIGH July 26, 1993
188 7307 Bioanalytical Systems BAS 482 476 Acetylcholine/choline 7 HIGH July 26, 1993
191 4035 Abbott Bichromatic ABA 100 407 Acid Phosphatase 2 HIGH July 26, 1993
192 4036 Abbott Bichromatic ABA 200 407 Acid Phosphatase 2 HIGH July 26, 1993
213 13216 DMA Test Kit 407 Acid Phosphatase 2 HIGH July 26, 1993
223 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 407 Acid Phosphatase 2 HIGH July 26, 1993
234 16010 Electronucleonics FLEXIGEM 407 Acid Phosphatase 2 HIGH July 26, 1993
239 K902495 25222 Horizon Acid Phosphatase (manual) 407 Acid Phosphatase 2 HIGH April 28, 1995
247 28183 Instrumentation Laboratory Multistat III 407 Acid Phosphatase 2 HIGH July 26, 1993
271 40118 Meditech Diagnostic System Test Kit 407 Acid Phosphatase 2 HIGH July 26, 1993
289 49064 Pointe Scientific 180 Chemistry Analyzer 407 Acid Phosphatase 2 HIGH July 26, 1993
290 55075 Reagents Applications RAICHEM Test Kit (manual) 407 Acid Phosphatase 2 HIGH July 26, 1993
302 58051 Sigma Diagnostics Test Kit 407 Acid Phosphatase 2 HIGH July 26, 1993
303 58157 Stanbio Test Kit 407 Acid Phosphatase 2 HIGH July 26, 1993
304 58229 Sterling Diagnostics Analyzer 2000 407 Acid Phosphatase 2 HIGH July 26, 1993
305 K882938 61377 TECO Diagnostics TC 84 407 Acid Phosphatase 2 HIGH November 19, 1998
306 61044 TRACE Scientific Test Kit 407 Acid Phosphatase 2 HIGH July 26, 1993
313 4424 All Manual Tilt-Tube Coagulation Procedures 461 Activated Clotting Time (ACT) 4 HIGH July 26, 1993
334 K980885 58535 Shield Diagnostics Activated Factor XII (FXIIa) ELISA 541 Activated Factor XII (FXIIa) 4 HIGH October 16, 1998
335 4424 All Manual Tilt-Tube Coagulation Procedures 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH July 26, 1993
344 K955450 7777 Behring Pathromtin SL APTT (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH May 24, 1996
356 K941210 13312 Diagnostica Stago PTT-LT Test Kit (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH January 27, 2000
363 K935169 25158 Helena Laboratories APTT-ES (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH December 9, 1994
412 K934351 40192 MeDiTech APTT-ES (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH June 10, 1994
456 K920001 67089 Vitek HEMOLAB Silimat (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH September 30, 1994
457 K926012 4424 All Manual Tilt-Tube Coagulation Procedures 499 Activated Plasma Clotting Time (APCT) 4 HIGH November 22, 1993
458 K945940 10286 Chromogenix COATEST APC Resistance (manual) 526 Activated Protein C (APC) Resistance 4 HIGH August 11, 1995
459 K963111 10388 Chromogenix COATEST APC Resistance V (manual) 526 Activated Protein C (APC) Resistance 4 HIGH January 17, 1997
460 K963111 10389 Chromogenix COATEST APC Resistance V-S (manual) 526 Activated Protein C (APC) Resistance 4 HIGH January 17, 1997
463 13091 Du Pont RIANEN RIA Kit 472 Adenosine Monophosphate, Cyclic (cAMP) 6 HIGH July 26, 1993
464 4208 Analytab API Adenovirus EIA (including cell culture/visual) 410 Adenovirus 10 HIGH July 26, 1993
465 4352 Analytab API Adenovirus Test Kit (including cell culture/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
466 4210 Analytab API Adenovirus Test Kit (IFA) (including cell culture) 410 Adenovirus 10 HIGH July 26, 1993
467 4255 Analytab API Adenovirus Test Kit-EIA (direct Ag/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
468 4209 Analytab API Adenovirus Test Kit-EIA (direct Ag/visual) 410 Adenovirus 10 HIGH July 26, 1993
469 4212 Analytab API Adenovirus Type 40/41 EIA (direct Ag/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
470 4211 Analytab API Adenovirus Type 40/41 EIA (direct Ag/visual) 410 Adenovirus 10 HIGH July 26, 1993
471 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 410 Adenovirus 10 HIGH September 1, 1994
472 10005 Cambridge Biotech Adenoclone IFA (including cell culture) 410 Adenovirus 10 HIGH July 26, 1993
473 10136 Cambridge Biotech Adenoclone-EIA (direct Ag/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
474 10004 Cambridge Biotech Adenoclone-EIA (direct Ag/visual) 410 Adenovirus 10 HIGH July 26, 1993
475 10178 Cambridge Biotech Adenoclone-EIA (including cell culture/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
476 10138 Cambridge Biotech Adenoclone-type 40/41 (direct Ag/spectrophotometric) 410 Adenovirus 10 HIGH July 26, 1993
477 10006 Cambridge Biotech Adenoclone-type 40/41 (direct Ag/visual) 410 Adenovirus 10 HIGH July 26, 1993
478 13456 DAKO IMAGEN Adenovirus (direct specimen) 410 Adenovirus 10 HIGH June 20, 1997
479 13457 DAKO IMAGEN Adenovirus (including cell culture) 410 Adenovirus 10 HIGH June 20, 1997
480 22104 Gull Laboratories Adenovirus Test (including cell culture) 410 Adenovirus 10 HIGH July 26, 1993
481 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 410 Adenovirus 10 HIGH January 18, 2000
482 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 410 Adenovirus 10 HIGH November 22, 1993
485 K990630 58584 SA Scientific SAS Adeno Test (including cell culture) 410 Adenovirus 10 HIGH October 8, 1999
486 K972406 70219 Wampole Adenovirus Ag Detection ELISA 410 Adenovirus 10 HIGH May 15, 1998
487 7313 Bio-Medical Virotech ELISA Antibody Test 411 Adenovirus Antibodies 3 HIGH July 26, 1993
488 K982608 4839 Alfa Scientific Designs ACTH ELISA 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 23, 1999
491 13031 Diagnostic Products Corp. Double Antibody 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
492 13189 Diagnostic Systems ACTH RIA Kit 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
493 28202 Incstar ACTH 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
494 28203 Incstar PEG-ACTH 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
496 43008 Nichols Institute Allegro RIA 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
497 K926396 43074 Nichols Institute Chemiluminescence ACTH Assay 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH November 22, 1993
498 43044 Nichols Institute RIA Kit 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH July 26, 1993
499 K982608 58537 Sangui BioTech ACTH ELISA 458 Adrenocorticotropic Hormone (ACTH) 6 HIGH October 30, 1998
500 K945433 4592 AB Biodisk Etest (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH March 24, 1995
501 4057 Abbott MS-2/Advantage (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
502 4059 Abbott Quantum II System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
503 K926002 4531 Alamar Bacterial Identification Panel (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH May 20, 1994
504 4637 All Antimicrobial Susceptibility (disk diffusion/dilution/from culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 9, 1995
505 4636 All Conventional Organism Identification (ID) (from culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 9, 1995
507 4365 All Manual Nucleic Acid Analysis Test Systems & Procedures 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
508 4193 Analytab API 20 Streptococcus (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
509 4194 Analytab API 20-A (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
510 K924814 4513 Analytab API 20E/UniScept 20E (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
511 4256 Analytab API ALADIN (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
512 4196 Analytab API An-Ident (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
513 4198 Analytab API Rapid E (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
514 4199 Analytab API Rapid NFT (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
515 4200 Analytab API Rapid Strep (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
516 4206 Analytab API UniScept System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
517 4207 Analytab API ZYM Microorganism Differentiation (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
518 4217 Analytab Staph-Ident (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
519 7023 Baxter AutoSCAN Walk/Away (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
520 7037 Baxter Haemophilus/Neisseria Identif-Panel (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
521 7042 Baxter MicroScan AutoSCAN 4 (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
527 K944528 7561 Becton Dickinson BBL CRYSTAL ANR ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH March 17, 1995
528 K961730 7919 Becton Dickinson BBL CRYSTAL GP ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH June 20, 1997
529 K962423 7807 Becton Dickinson BBL CRYSTAL N/H ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH October 25, 1996
530 K961968 7920 Becton Dickinson BBL CRYSTAL Rapid GP ID Sys (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH June 20, 1997
531 7360 Becton Dickinson BBL Minitek Enterobact. III Set (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
532 7361 Becton Dickinson BBL Minitek Gram Positive Set (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
533 7362 Becton Dickinson BBL Minitek Neisseria Set (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
534 K926018 7485 Becton Dickinson Crystal E/NF ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
535 K926017 7484 Becton Dickinson Crystal RS/E ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
536 7203 Becton Dickinson Sceptor System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
537 7267 BioClinical Systems Bullseye OB/GYN Plate (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
538 7268 BioClinical Systems UniSystem Bio-General (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
539 K954784 13407 Difco DrySlide NEISSERIA (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH February 2, 1996
541 28054 Innovative Diagnostic Systems IDS Rapid STR (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
542 28056 Innovative Diagnostic Systems Modified IDS Rapid NH (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
543 28059 Innovative Diagnostic Systems Rap ANA II (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
544 28060 Innovative Diagnostic Systems Rap NF Plus (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
545 28061 Innovative Diagnostic Systems Rapid NF (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
546 40073 Micro Media System Bacterial ID Panels /Gram Neg /Gram Pos (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
547 K945997 40201 Micro Media System Microdilution MIC/ID Panels (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH March 3, 1995
548 46004 Organon Autobac Series II (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
552 49017 Pasco MIC/ID System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
553 49012 Pro-Lab Neisseria/Branhamella Diff. Test (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
554 K923342 55115 Radiometer Microbact 12A & 12A+12B G/neg ID Sys (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
555 55009 Radiometer Sensititre (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
556 55025 Remel Haemophilus ID Test Kit (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
557 55047 Roche Diagnostics Enterotube II (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
558 K923313 55116 Roche Diagnostics Oxi/Ferm II (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
559 61029 Troy Biologicals Bacti-Bio General Plate (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
560 61031 Troy Biologicals Bacti-Star II Vaginal Plate (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
561 61032 Troy Biologicals Bacti-Star Vaginal Plate (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
562 61033 Troy Biologicals Bacti-Vaginal Plate (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
563 64020 Unipath Oxoid Toxin Detection Kit BCET-RPLA (including culture/from filtrate) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
564 64005 Unipath Oxoid Toxin Detection Kit PET-RPLA (including culture/from filtrate) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
565 64021 Unipath Oxoid Toxin Detection Kit SET-RPLA (including culture/from filtrate) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
566 64006 Unipath Oxoid Toxin Detection Kit TST-RPLA (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
567 64007 Unipath Oxoid Toxin Detection Kit VET-RPLA (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
568 67032 Vitek Systems Rapid E System (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
569 K922768 67076 Vitek Systems Rapid NFT (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH November 22, 1993
571 61026 Troy Biologicals Bacti Strep Screen Plus (including culture) 413 Aerobic Organisms from throat specimens only 8 HIGH July 26, 1993
572 61027 Troy Biologicals Bacti-Star II Throat Plate (including culture) 413 Aerobic Organisms from throat specimens only 8 HIGH July 26, 1993
573 61028 Troy Biologicals Bacti-Star Throat Plate (including culture) 413 Aerobic Organisms from throat specimens only 8 HIGH July 26, 1993
574 61030 Troy Biologicals Bacti-Throat Plate (including culture) 413 Aerobic Organisms from throat specimens only 8 HIGH July 26, 1993
576 4548 Adams Scientific Selecticult-U (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
579 7539 BioClinical Systems Bullseye Urine Plate (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
581 K972676 10442 Combact Cellenium-160US 468 Aerobic Organisms from urine specimens only 8 HIGH June 12, 1998
584 10262 Culture Kits Uri-Three (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
586 10333 Culture Kits Uri-Two (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH April 26, 1996
589 19022 Future Medical Tech. Intl. Qualture (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
590 28053 Innovative Diagnostic Systems IDS Rapid SS/U (including culture) 468 Aerobic Organisms from urine specimens only 8 HIGH February 3, 1995
597 58541 Sanofi Pasteur UriSelect 3 (organism ID) 468 Aerobic Organisms from urine specimens only 8 HIGH November 19, 1998
604 61142 Troy Biologicals Bacti-Star II Urine System (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
605 61143 Troy Biologicals Bacti-Star Urine Plate (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
607 61144 Troy Biologicals Bacti-Urine Plate (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
609 61145 Troy Biologicals Uri-Check Plus (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH December 23, 1994
612 64028 UTI-tect Bacteriuria Diagnostic Test System (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH January 6, 1995
621 7931 bioMerieux Vitek CPS ID 2 (non-confirmatory ID) 468 Aerobic Organisms from urine specimens only 8 HIGH August 22, 1997
627 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 511 Alanine 2 HIGH November 10, 1994
628 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 511 Alanine 2 HIGH May 26, 1995
632 4035 Abbott Bichromatic ABA 100 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
633 4036 Abbott Bichromatic ABA 200 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
634 4267 Abbott Bichromatic ABA 50 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
645 4143 American Monitor KDA 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
646 4144 American Monitor Parallel 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
648 4275 Ames OPTIMATE 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
656 7378 Beckman Manual Spectrophotometric Test Procedure 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
694 13216 DMA Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
705 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
719 16010 Electronucleonics FLEXIGEM 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
724 22145 Genetic Systems Alanine Aminotransferase (ALT/GPT) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
726 K951818 25227 HiChem Alanine Transaminase (ALT) Reagent Kit (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH May 26, 1995
727 K880279 25216 Horizon ALT (SGPT) (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH April 28, 1995
735 28183 Instrumentation Laboratory Multistat III 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
736 28184 Instrumentation Laboratory Multistat III Plus 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
764 40126 Mallinckrodt Serometer 370 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
765 K952744 40216 MeDiTech Alanine Aminotransferase (ALT) (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH August 18, 1995
766 40124 Medical Analysis Systems RefLab Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
767 40118 Meditech Diagnostic System Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
785 K941192 46167 Ortho ALT Microwell Test System (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH May 19, 1995
793 49064 Pointe Scientific 180 Chemistry Analyzer 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
795 55106 Randox Laboratories Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
796 55075 Reagents Applications RAICHEM Test Kit (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
820 K941497 58337 STC Technologies ALT Micro-Plate Assay 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH October 28, 1994
825 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
826 58185 Seragen StatEase 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
827 58051 Sigma Diagnostics Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
828 58195 SmithKline ESKALAB-CCS 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
829 58210 Stanbio Premiere 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
830 58229 Sterling Diagnostics Analyzer 2000 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
831 58230 Sterling Diagnostics Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
833 K864906 61398 TECO Diagnostics Alanine Aminotransferase (ALT) Reagent Set (manual) 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH March 26, 1999
834 K882938 61377 TECO Diagnostics TC 84 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH November 19, 1998
835 61044 TRACE Scientific Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
846 61014 Technicon SMA 12/60 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
847 61016 Technicon SMAC 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
848 61045 Technicon SMAC 2 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
849 61046 Technicon SMAC 3 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
851 70102 Wako Autokit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
857 4035 Abbott Bichromatic ABA 100 414 Albumin 2 HIGH July 26, 1993
858 4036 Abbott Bichromatic ABA 200 414 Albumin 2 HIGH July 26, 1993
859 4267 Abbott Bichromatic ABA 50 414 Albumin 2 HIGH July 26, 1993
870 4143 American Monitor KDA 414 Albumin 2 HIGH July 26, 1993
872 4275 Ames OPTIMATE 414 Albumin 2 HIGH July 26, 1993
880 7383 Beckman Auto ICS 414 Albumin 2 HIGH July 26, 1993
881 7381 Beckman ICS 414 Albumin 2 HIGH July 26, 1993
921 13216 DMA Test Kit 414 Albumin 2 HIGH July 26, 1993
931 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 414 Albumin 2 HIGH July 26, 1993
943 16010 Electronucleonics FLEXIGEM 414 Albumin 2 HIGH July 26, 1993
949 25055 Helena Laboratories Low Level Quiplate System for RID 414 Albumin 2 HIGH July 26, 1993
950 K880844 25204 Horizon Serum Albumin (manual) 414 Albumin 2 HIGH April 28, 1995
957 28183 Instrumentation Laboratory Multistat III 414 Albumin 2 HIGH July 26, 1993
976 34001 Kallestad Endoplate RID 414 Albumin 2 HIGH July 26, 1993
977 34003 Kallestad Quantiplate RID 414 Albumin 2 HIGH July 26, 1993
989 40126 Mallinckrodt Serometer 370 414 Albumin 2 HIGH July 26, 1993
990 40123 Medical Analysis Systems Test Kit 414 Albumin 2 HIGH July 26, 1993
991 40118 Meditech Diagnostic System Test Kit 414 Albumin 2 HIGH July 26, 1993
1013 49064 Pointe Scientific 180 Chemistry Analyzer 414 Albumin 2 HIGH July 26, 1993
1015 55075 Reagents Applications RAICHEM Test Kit (manual) 414 Albumin 2 HIGH July 26, 1993
1040 58051 Sigma Diagnostics Test Kit 414 Albumin 2 HIGH July 26, 1993
1041 58195 SmithKline ESKALAB-CCS 414 Albumin 2 HIGH July 26, 1993
1042 58210 Stanbio Premiere 414 Albumin 2 HIGH July 26, 1993
1043 58229 Sterling Diagnostics Analyzer 2000 414 Albumin 2 HIGH July 26, 1993
1045 K875070 61396 TECO Diagnostics Albumin Reagent Set (manual) 414 Albumin 2 HIGH March 26, 1999
1046 K882938 61377 TECO Diagnostics TC 84 414 Albumin 2 HIGH November 19, 1998
1047 K923322 61118 TRACE Scientific Albumin BCG Modified Reactivity (manual) 414 Albumin 2 HIGH November 22, 1993
1048 61044 TRACE Scientific Test Kit 414 Albumin 2 HIGH July 26, 1993
1061 61014 Technicon SMA 12/60 414 Albumin 2 HIGH July 26, 1993
1062 61016 Technicon SMAC 414 Albumin 2 HIGH July 26, 1993
1063 61045 Technicon SMAC 2 414 Albumin 2 HIGH July 26, 1993
1064 61077 The Binding Site Human Albumin NL RID 414 Albumin 2 HIGH July 26, 1993
1065 70102 Wako Autokit 414 Albumin 2 HIGH July 26, 1993
1068 28188 Isolab Glyc-Affin GA 471 Albumin, Glycated 2 HIGH July 26, 1993
1077 7226 Behring Stat-Pack Aldolase Test 415 Aldolase 2 HIGH July 26, 1993
1082 28183 Instrumentation Laboratory Multistat III 415 Aldolase 2 HIGH July 26, 1993
1083 28184 Instrumentation Laboratory Multistat III Plus 415 Aldolase 2 HIGH July 26, 1993
1088 58051 Sigma Diagnostics Test Kit 415 Aldolase 2 HIGH July 26, 1993
1089 13030 Diagnostic Products Corp. Coat-A-Count 459 Aldosterone 6 HIGH July 26, 1993
1090 K943397 13315 Diagnostic Systems DSL ACTIVE Aldosterone RIA Kit 459 Aldosterone 6 HIGH February 17, 1995
1093 4035 Abbott Bichromatic ABA 100 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1094 4036 Abbott Bichromatic ABA 200 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1095 4267 Abbott Bichromatic ABA 50 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1106 4143 American Monitor KDA 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1107 4144 American Monitor Parallel 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1108 4275 Ames OPTIMATE 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1114 7378 Beckman Manual Spectrophotometric Test Procedure 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1150 13216 DMA Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1160 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1173 16010 Electronucleonics FLEXIGEM 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1178 K963383 25262 HiChem Alkaline Phosphatase Reagent Kit (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH October 25, 1996
1179 K930810 25170 Hybritech Tandem-R Ostase 416 Alkaline Phosphatase (ALP) 2 HIGH October 14, 1994
1187 28183 Instrumentation Laboratory Multistat III 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1188 28184 Instrumentation Laboratory Multistat III Plus 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1219 40126 Mallinckrodt Serometer 370 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1220 K952746 40240 MeDiTech Alkaline Phosphatase (ALP) (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH December 15, 1995
1221 40124 Medical Analysis Systems RefLab Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1222 40118 Meditech Diagnostic System Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1246 49064 Pointe Scientific 180 Chemistry Analyzer 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1248 55106 Randox Laboratories Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1249 55075 Reagents Applications RAICHEM Test Kit (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1273 58051 Sigma Diagnostics Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1274 58195 SmithKline ESKALAB-CCS 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1275 58157 Stanbio Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1276 58230 Sterling Diagnostics Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1279 K931986 58260 Synermed Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH May 20, 1994
1280 K880177 61397 TECO Diagnostics Alkaline Phosphatase Reagent Set (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH March 26, 1999
1281 K882938 61377 TECO Diagnostics TC 84 416 Alkaline Phosphatase (ALP) 2 HIGH November 19, 1998
1282 61044 TRACE Scientific Test Kit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1293 61016 Technicon SMAC 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1294 61045 Technicon SMAC 2 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1295 61046 Technicon SMAC 3 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1297 70102 Wako Autokit 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
1303 K972666 25281 Hybritech Tandem-MP Ostase (automated curve) 518 Alkaline Phosphatase Bone Specific (BAP) 2 HIGH February 6, 1998
1304 K972666 25280 Hybritech Tandem-MP Ostase (manual curve) 518 Alkaline Phosphatase Bone Specific (BAP) 2 HIGH February 6, 1998
1305 K961573 25170 Hybritech Tandem-R Ostase 518 Alkaline Phosphatase Bone Specific (BAP) 2 HIGH November 8, 1996
1306 K952768 40227 Metra Biosystems Alkphase-B 518 Alkaline Phosphatase Bone Specific (BAP) 2 HIGH September 15, 1995
1307 7367 Beckman Paragon ISOPAL Isoenzyme Electrophoresis Kit 469 Alkaline Phosphatase Isoenzymes 2 HIGH July 26, 1993
1308 25082 Helena Laboratories Alk. Phosphatase Isoenzyme Procedure 469 Alkaline Phosphatase Isoenzymes 2 HIGH July 26, 1993
1309 28156 Isolab Resolve-ALP 469 Alkaline Phosphatase Isoenzymes 2 HIGH July 26, 1993
1310 4004 ALerCHEK FlipSCREEN II Visual Allergy Test 417 Allergen specific IgE 3 HIGH July 26, 1993
1311 4006 ALerCHEK FlipSCREEN quantitative Allergy Tests 417 Allergen specific IgE 3 HIGH July 26, 1993
1313 7314 BioWhittaker 3M Allergen Specific IgE FAST-Plus Test 417 Allergen specific IgE 3 HIGH July 26, 1993
1314 7316 BioWhittaker 3M IgE FASTSCREEN Test 417 Allergen specific IgE 3 HIGH July 26, 1993
1315 10055 Ciba Corning Magic Lite 417 Allergen specific IgE 3 HIGH July 26, 1993
1316 K923420 10245 Ciba Corning Magic Lite SQ Specific IgE Immunoassay 417 Allergen specific IgE 3 HIGH November 22, 1993
1326 13026 Diagnostic Products Corp. AlaSTAT Allergen Specific IgE 417 Allergen specific IgE 3 HIGH July 26, 1993
1329 13206 Diagnostic Products Corp. AlaTOP Allergy Screen 417 Allergen specific IgE 3 HIGH July 26, 1993
1330 13169 Diagnostic Products Corp. Milenia AlaSTAT 417 Allergen specific IgE 3 HIGH July 26, 1993
1331 K925425 25146 Hycor Biomedical Specific IgE EIA-TURBO 417 Allergen specific IgE 3 HIGH November 22, 1993
1332 K925044 25145 Hycor Biomedical Specific IgE RIA Isotope Unit 417 Allergen specific IgE 3 HIGH November 22, 1993
1334 K941278 25175 Hycor HY-TEC Specific IgE - EIA (manual) 417 Allergen specific IgE 3 HIGH March 17, 1995
1335 K941057 25166 Hycor Ultra-EIA Specific IgE Assay 417 Allergen specific IgE 3 HIGH February 3, 1995
1338 28125 In Vitro Technologies IVT RAST Tracer Unit 417 Allergen specific IgE 3 HIGH July 26, 1993
1343 34042 Kallestad Allercoat EAST 417 Allergen specific IgE 3 HIGH July 26, 1993
1344 34043 Kallestad Allercoat RAST 417 Allergen specific IgE 3 HIGH July 26, 1993
1345 34041 Kallestad Allercoat Rapid EAST 417 Allergen specific IgE 3 HIGH July 26, 1993
1346 40176 MAST CLA Allergy System (densitometer) 417 Allergen specific IgE 3 HIGH May 15, 1995
1347 40112 MAST CLA Allergy Systems (chemiluminescence) 417 Allergen specific IgE 3 HIGH July 26, 1993
1348 40177 MAST CLA-1 Chemiluminescent Allergy System 417 Allergen specific IgE 3 HIGH May 15, 1995
1351 49047 Pharmacia CAP System RAST FEIA 417 Allergen specific IgE 3 HIGH July 26, 1993
1352 49048 Pharmacia CAP System RAST RIA 417 Allergen specific IgE 3 HIGH July 26, 1993
1353 49043 Pharmacia Phadebas RAST 417 Allergen specific IgE 3 HIGH July 26, 1993
1354 49042 Pharmacia Phadebas RAST Penicilloyl G/Penicilloyl V 417 Allergen specific IgE 3 HIGH July 26, 1993
1355 49041 Pharmacia Phadezym RAST 417 Allergen specific IgE 3 HIGH July 26, 1993
1356 49044 Pharmacia Phadiatop EIA 417 Allergen specific IgE 3 HIGH July 26, 1993
1357 49045 Pharmacia Phadiatop RIA 417 Allergen specific IgE 3 HIGH July 26, 1993
1363 67056 Ventrex Specific IgE EIA 417 Allergen specific IgE 3 HIGH July 26, 1993
1364 67057 Ventrex Specific IgE RAST Isotope Unit 417 Allergen specific IgE 3 HIGH July 26, 1993
1365 67059 Ventrex TURBO-RAST Specific IgE Isotope Unit 417 Allergen specific IgE 3 HIGH July 26, 1993
1366 49038 Pharmacia IgG RAST EIA 418 Allergen specific IgG 3 HIGH July 26, 1993
1367 49037 Pharmacia IgG RAST RIA 418 Allergen specific IgG 3 HIGH July 26, 1993
1375 7383 Beckman Auto ICS 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
1376 7381 Beckman ICS 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
1377 7382 Beckman ICS II 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
1387 25024 Hycor Accuplate 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
1394 55075 Reagents Applications RAICHEM Test Kit (manual) 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
1412 K922417 61140 The Binding Site BIND A RID Human Alpha-1 Acid Glycoprotein 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH October 14, 1994
1417 7383 Beckman Auto ICS 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1418 7381 Beckman ICS 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1419 7382 Beckman ICS II 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1437 25005 Helena Laboratories Quiplate System for RID 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1438 25024 Hycor Accuplate 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1443 28183 Instrumentation Laboratory Multistat III 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1444 28184 Instrumentation Laboratory Multistat III Plus 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1445 34001 Kallestad Endoplate RID 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1446 34003 Kallestad Quantiplate RID 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1447 34010 Kent Radial Immunodiffusion Test 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1477 61079 The Binding Site Human Alpha-1 Antitrypsin RID 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
1479 K983460 4875 American Bioproducts STA-R Analyzer 463 Alpha-2-Antiplasmin 4 HIGH October 25, 1999
1480 K955278 7824 Behring Coagulation Timer (BCT) 463 Alpha-2-Antiplasmin 4 HIGH November 15, 1996
1481 K941752 7602 Biopool Spectrolyse alpha2-antiplasmin Kit 463 Alpha-2-Antiplasmin 4 HIGH January 27, 2000
1482 K981817 10456 Chromogenix Coamatic Plasmin Inhibitor (manual) 463 Alpha-2-Antiplasmin 4 HIGH December 8, 1998
1483 K970431 13608 Dade Behring Coagulation System (BCS) 463 Alpha-2-Antiplasmin 4 HIGH January 26, 2000
1484 13209 Diagnostica Stago STACHROM Antiplasmin 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1485 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1486 K981696 28073 Instrumentation Laboratory IL ACL 100 463 Alpha-2-Antiplasmin 4 HIGH December 8, 1998
1487 K981696 28074 Instrumentation Laboratory IL ACL 1000 463 Alpha-2-Antiplasmin 4 HIGH December 8, 1998
1488 28075 Instrumentation Laboratory IL ACL 200 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1489 28076 Instrumentation Laboratory IL ACL 2000 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1490 28077 Instrumentation Laboratory IL ACL 300 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1491 K981817 28544 Instrumentation Laboratory IL ACL 300 {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1492 28197 Instrumentation Laboratory IL ACL 300 Plus 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1493 28078 Instrumentation Laboratory IL ACL 3000 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1494 28079 Instrumentation Laboratory IL ACL 3000 Plus 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1495 K961991 28454 Instrumentation Laboratory IL ACL 6000 463 Alpha-2-Antiplasmin 4 HIGH September 13, 1996
1496 K961991 28487 Instrumentation Laboratory IL ACL 7000 463 Alpha-2-Antiplasmin 4 HIGH September 19, 1997
1497 28080 Instrumentation Laboratory IL ACL 810 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1498 K981696 28395 Instrumentation Laboratory IL ACL Futura System 463 Alpha-2-Antiplasmin 4 HIGH December 8, 1998
1499 40037 Medical Laboratory MLA Electra 1000 C 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1500 K981817 40317 Medical Laboratory MLA Electra 1000C {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1501 K944227 40208 Medical Laboratory MLA Electra 1400C 463 Alpha-2-Antiplasmin 4 HIGH April 7, 1995
1502 K981817 40318 Medical Laboratory MLA Electra 1400C {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1503 K931206 40167 Medical Laboratory MLA Electra 1600C 463 Alpha-2-Antiplasmin 4 HIGH November 22, 1993
1504 K981817 40319 Medical Laboratory MLA Electra 1600C {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1505 K962664 40282 Medical Laboratory MLA Electra 1800C 463 Alpha-2-Antiplasmin 4 HIGH December 5, 1997
1506 40042 Medical Laboratory MLA Electra 900C 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1507 K981817 40316 Medical Laboratory MLA Electra 900C {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1508 46094 Organon Teknika Chromostrate Alpha-2-Antiplasmin Assay 463 Alpha-2-Antiplasmin 4 HIGH July 26, 1993
1509 K981817 55313 Roche Diagnostics Cobas Mira {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
1510 K993174 61283 TOA Medical Electronics CA-6000 463 Alpha-2-Antiplasmin 4 HIGH January 18, 2000
1514 7383 Beckman Auto ICS 422 Alpha-2-Macroglobulin 3 HIGH July 26, 1993
1515 7381 Beckman ICS 422 Alpha-2-Macroglobulin 3 HIGH July 26, 1993
1516 7382 Beckman ICS II 422 Alpha-2-Macroglobulin 3 HIGH July 26, 1993
1523 34010 Kent Radial Immunodiffusion Test 422 Alpha-2-Macroglobulin 3 HIGH July 26, 1993
1526 61078 The Binding Site Human Alpha-2 Macroglobulin RID 422 Alpha-2-Macroglobulin 3 HIGH July 26, 1993
1527 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 512 Alpha-Amino-n-butyric Acid 2 HIGH November 10, 1994
1528 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 512 Alpha-Amino-n-butyric Acid 2 HIGH May 26, 1995
1529 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 510 Alpha-Aminoadipic Acid 2 HIGH November 10, 1994
1530 4023 Abbott AFP EIA 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1531 4334 Abbott COMMANDER System 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1532 4056 Abbott IMX 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1533 4146 Amersham Amerlex 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1534 P980041 7914 Beckman ACCESS Immunoassay System 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH October 8, 1999
1535 P930036 10375 Chiron Diagnostics ACS 180 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH April 4, 1997
1536 K940810 10376 Chiron Diagnostics ACS 180 Plus 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH February 20, 1998
1537 K971418 10440 Chiron Diagnostics ACS:Centaur 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH April 24, 1998
1538 10061 Clinical Assays GammaDab 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1539 25022 Hybritech Tandem-E 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1540 34045 Kallestad AFP/Ob Radioimmunoassay 484 Alpha-Fetoprotein - Amniotic Fluid 2 HIGH July 26, 1993
1541 4023 Abbott AFP EIA 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1542 4334 Abbott COMMANDER System 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1543 4056 Abbott IMX 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1544 4146 Amersham Amerlex 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1545 P980041 7914 Beckman ACCESS Immunoassay System 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH October 8, 1999
1546 P930036 10375 Chiron Diagnostics ACS 180 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH April 4, 1997
1547 K971418 10440 Chiron Diagnostics ACS:Centaur 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH April 24, 1998
1548 10061 Clinical Assays GammaDab 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1549 25022 Hybritech Tandem-E 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1550 34045 Kallestad AFP/Ob Radioimmunoassay 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH July 26, 1993
1551 4023 Abbott AFP EIA 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
1552 4334 Abbott COMMANDER System 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
1554 4146 Amersham Amerlex 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
1564 10061 Clinical Assays GammaDab 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
1565 13031 Diagnostic Products Corp. Double Antibody 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
1576 4035 Abbott Bichromatic ABA 100 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1577 4036 Abbott Bichromatic ABA 200 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1578 4267 Abbott Bichromatic ABA 50 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1583 4275 Ames OPTIMATE 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1611 16010 Electronucleonics FLEXIGEM 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1617 28183 Instrumentation Laboratory Multistat III 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1618 28184 Instrumentation Laboratory Multistat III Plus 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1619 40123 Medical Analysis Systems Test Kit 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1622 55075 Reagents Applications RAICHEM Test Kit (manual) 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1632 58051 Sigma Diagnostics Test Kit 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1633 58230 Sterling Diagnostics Test Kit 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
1634 K941427 61152 TECO Diagnostics HBDH Reagent Set (manual) 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH March 17, 1995
1639 4275 Ames OPTIMATE 425 Amikacin 7 HIGH July 26, 1993
1640 4156 Ames TDA 425 Amikacin 7 HIGH July 26, 1993
1650 13030 Diagnostic Products Corp. Coat-A-Count 425 Amikacin 7 HIGH July 26, 1993
1662 28183 Instrumentation Laboratory Multistat III 425 Amikacin 7 HIGH July 26, 1993
1673 58082 Syva Emit Test Kit 425 Amikacin 7 HIGH July 26, 1993
1677 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 513 Aminoethylcysteine 2 HIGH November 10, 1994
1681 4035 Abbott Bichromatic ABA 100 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1682 4036 Abbott Bichromatic ABA 200 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1700 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 427 Ammonia, Plasma/Serum 2 HIGH November 10, 1994
1704 K953239 7766 Boehringer Mannheim Ammonia (manual) 427 Ammonia, Plasma/Serum 2 HIGH March 22, 1996
1723 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1741 28183 Instrumentation Laboratory Multistat III 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1742 28184 Instrumentation Laboratory Multistat III Plus 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1781 55075 Reagents Applications RAICHEM Test Kit (manual) 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1782 K953239 55332 Roche Diagnostics Ammonia (manual) 427 Ammonia, Plasma/Serum 2 HIGH May 7, 1999
1797 58051 Sigma Diagnostics Test Kit 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1798 K915707 61399 TECO Diagnostics Ammonia Reagent Set (manual) 427 Ammonia, Plasma/Serum 2 HIGH March 26, 1999
1804 70100 Wako Ammonia Test Kit 427 Ammonia, Plasma/Serum 2 HIGH July 26, 1993
1815 4275 Ames OPTIMATE 428 Amphetamines 7 HIGH July 26, 1993
1823 K951154 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1828 K951154 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1833 K951154 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH April 10, 1998
1842 K943993 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1844 K943993 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1849 K943993 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1852 K943993 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1863 13031 Diagnostic Products Corp. Double Antibody 428 Amphetamines 7 HIGH July 26, 1993
1864 13111 Diagnostic Products Corp. Milenia 428 Amphetamines 7 HIGH July 26, 1993
1878 19013 Finnigan MAT Witness System 428 Amphetamines 7 HIGH July 26, 1993
1884 28175 Immunotech Microzyme EIA (spectrophotometric) 428 Amphetamines 7 HIGH July 26, 1993
1889 28183 Instrumentation Laboratory Multistat III 428 Amphetamines 7 HIGH July 26, 1993
1890 28184 Instrumentation Laboratory Multistat III Plus 428 Amphetamines 7 HIGH July 26, 1993
1896 K932304 40191 Microdiagnostics MICRO EIA 428 Amphetamines 7 HIGH June 10, 1994
1901 K951154 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
1929 55098 Roche Diagnostics Abuscreen RIA 428 Amphetamines 7 HIGH July 26, 1993
1942 K943993 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH May 7, 1999
1947 K943993 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH May 7, 1999
1950 K943993 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH May 7, 1999
1961 K931498 58299 STC Technologies Amphetamines EIA Plate Kit 428 Amphetamines 7 HIGH November 22, 1993
1962 K935573 58374 STC Technologies Amphetamines M-Plate EIA {Sudormed Patch} 428 Amphetamines 7 HIGH August 25, 1995
1963 58103 Sigma Diagnostics SIA Methamphetamine/Amphetamine 428 Amphetamines 7 HIGH July 26, 1993
1968 58188 Syva Emit st Drug Detection System 428 Amphetamines 7 HIGH July 26, 1993
1969 58190 Syva Qstat/Qst System 428 Amphetamines 7 HIGH July 26, 1993
1976 K934693 64026 USDT Flow Immunoassay System 428 Amphetamines 7 HIGH May 20, 1994
1977 K973153 64040 United Biotech UBI MAGIWEL ELISA for Amphetamine Metabolites 428 Amphetamines 7 HIGH April 10, 1998
1984 4035 Abbott Bichromatic ABA 100 429 Amylase 2 HIGH July 26, 1993
1985 4036 Abbott Bichromatic ABA 200 429 Amylase 2 HIGH July 26, 1993
1986 4267 Abbott Bichromatic ABA 50 429 Amylase 2 HIGH July 26, 1993
2003 7378 Beckman Manual Spectrophotometric Test Procedure 429 Amylase 2 HIGH July 26, 1993
2016 7228 Behring Pantrak Amylase Test 429 Amylase 2 HIGH July 26, 1993
2041 13216 DMA Test Kit 429 Amylase 2 HIGH July 26, 1993
2052 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 429 Amylase 2 HIGH July 26, 1993
2065 16010 Electronucleonics FLEXIGEM 429 Amylase 2 HIGH July 26, 1993
2070 K933397 22164 Genzyme Test Kit 429 Amylase 2 HIGH May 20, 1994
2079 28183 Instrumentation Laboratory Multistat III 429 Amylase 2 HIGH July 26, 1993
2080 28184 Instrumentation Laboratory Multistat III Plus 429 Amylase 2 HIGH July 26, 1993
2081 K932888 28321 Intersect Systems Test Kit 429 Amylase 2 HIGH June 10, 1994
2112 40126 Mallinckrodt Serometer 370 429 Amylase 2 HIGH July 26, 1993
2113 40124 Medical Analysis Systems RefLab Test Kit 429 Amylase 2 HIGH July 26, 1993
2114 40118 Meditech Diagnostic System Test Kit 429 Amylase 2 HIGH July 26, 1993
2139 49064 Pointe Scientific 180 Chemistry Analyzer 429 Amylase 2 HIGH July 26, 1993
2140 K930475 49103 Pointe Scientific Manual Amylase Test 429 Amylase 2 HIGH November 22, 1993
2142 55075 Reagents Applications RAICHEM Test Kit (manual) 429 Amylase 2 HIGH July 26, 1993
2164 58051 Sigma Diagnostics Test Kit 429 Amylase 2 HIGH July 26, 1993
2165 58195 SmithKline ESKALAB-CCS 429 Amylase 2 HIGH July 26, 1993
2166 58210 Stanbio Premiere 429 Amylase 2 HIGH July 26, 1993
2167 58157 Stanbio Test Kit 429 Amylase 2 HIGH July 26, 1993
2168 58229 Sterling Diagnostics Analyzer 2000 429 Amylase 2 HIGH July 26, 1993
2169 58230 Sterling Diagnostics Test Kit 429 Amylase 2 HIGH July 26, 1993
2171 K931080 61156 TECO Diagnostics Amylase Reagent Set (manual) 429 Amylase 2 HIGH October 14, 1994
2172 K882938 61377 TECO Diagnostics TC 84 429 Amylase 2 HIGH November 19, 1998
2173 61044 TRACE Scientific Test Kit 429 Amylase 2 HIGH July 26, 1993
2209 13186 Diagnostic Systems Androstanediol Glucuronide RIA Kit 466 Androstanediol Glucuronide (3 alpha-diol G) 6 HIGH July 26, 1993
2210 10060 Clinical Assays GammaCoat 460 Androstenedione 6 HIGH July 26, 1993
2211 13030 Diagnostic Products Corp. Coat-A-Count 460 Androstenedione 6 HIGH July 26, 1993
2212 K954755 13411 Diagnostic Products Corp. Coat-A-Count Dir. Androstenedione 460 Androstenedione 6 HIGH February 9, 1996
2213 13204 Diagnostic Systems Active Androsteindione RIA Kit 460 Androstenedione 6 HIGH July 26, 1993
2214 13193 Diagnostic Systems Androsteindione RIA Kit 460 Androstenedione 6 HIGH July 26, 1993
2215 E990019 34094 KMI Diagnostics Androstenedione ELISA 460 Androstenedione 6 HIGH March 26, 1999
2216 K942497 4562 ALPCO Angiotensin Converting Enzyme REA 481 Angiotensin Converting Enzyme (ACE) 2 HIGH December 9, 1994
2217 4035 Abbott Bichromatic ABA 100 481 Angiotensin Converting Enzyme (ACE) 2 HIGH July 26, 1993
2218 4036 Abbott Bichromatic ABA 200 481 Angiotensin Converting Enzyme (ACE) 2 HIGH July 26, 1993
2233 28183 Instrumentation Laboratory Multistat III 481 Angiotensin Converting Enzyme (ACE) 2 HIGH July 26, 1993
2241 58051 Sigma Diagnostics Test Kit 481 Angiotensin Converting Enzyme (ACE) 2 HIGH July 26, 1993
2246 13091 Du Pont RIANEN RIA Kit 479 Angiotensin I 6 HIGH July 26, 1993
2247 K940004 49155 Pharmaceutical Discovery A-I Photodiagnostic 479 Angiotensin I 6 HIGH August 25, 1995
2248 K954299 4631 ALPCO Angiotensin II RIA 520 Angiotensin II 6 HIGH October 27, 1995
2249 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 514 Anserine 2 HIGH November 10, 1994
2250 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 514 Anserine 2 HIGH May 26, 1995
2251 K913617 25141 Hillcrest Biologicals Arbovirus (IgG) IFA Test 498 Anti-Arbovirus Antibodies 3 HIGH November 22, 1993
2252 K913618 25142 Hillcrest Biologicals Arbovirus (IgM) IFA Test 498 Anti-Arbovirus Antibodies 3 HIGH November 22, 1993
2253 K992241 25298 Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgA 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH November 1, 1999
2254 K992224 25296 Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgG 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH November 1, 1999
2255 K992243 25297 Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgM 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH November 1, 1999
2256 K973006 28493 INOVA Diagnostics QUANTA Lite B2 GPI IgA 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH November 7, 1997
2257 K970551 28484 INOVA Diagnostics QUANTA Lite B2 GPI IgG 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH July 18, 1997
2258 K973014 28494 INOVA Diagnostics QUANTA Lite B2 GPI IgM 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH November 7, 1997
2259 K980230 28524 INOVA Diagnostics QUANTA Lite B2 GPI Screen 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH April 10, 1998
2260 K982434 55642 Reaads Medical Products IgA Anti-Beta 2 Glycoprotein I Semi-quant Test Kit 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH October 25, 1999
2261 K982391 55640 Reaads Medical Products IgG Anti-Beta 2 Glycoprotein I Semi-quant Test Kit 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH October 25, 1999
2262 K982433 55641 Reaads Medical Products IgM Anti-Beta 2 Glycoprotein I Semi-quant Test Kit 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH October 25, 1999
2263 K982879 58542 Shield Diagnostics DIASTAT Anti-Beta 2 Glycoprotein 1 IgG (qualitative) 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH December 8, 1998
2264 K982879 58543 Shield Diagnostics DIASTAT Anti-Beta 2 Glycoprotein 1 IgG (semi-quanitative) 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH December 8, 1998
2269 K972790 61346 TheraTest Laboratories EL-B2GP1 (IgM, IgG, IgA) 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH January 16, 1998
2270 K973882 61345 TheraTest Laboratories EL-B2GP1scr 529 Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) 3 HIGH January 16, 1998
2271 58017 Scimedx CMA Test System 433 Anti-Cardiac Muscle Antibodies 3 HIGH July 26, 1993
2272 K962469 4672 ALPCO ORGenTec Anti-Cardiolipin (IgA) ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH October 4, 1996
2273 K955449 4668 ALPCO ORGenTec Anti-Cardiolipin (IgG/IgM) ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH June 21, 1996
2274 K962926 4688 ALPCO ORGenTec Anti-Cardiolipin (IgG/IgM/IgA) ELISA (screen) 434 Anti-Cardiolipin Antibodies 3 HIGH March 28, 1997
2275 K962926 4689 ALPCO ORGenTec Anti-Cardiolipin (IgG/IgM/IgA) ELISA (semi-quantitative) 434 Anti-Cardiolipin Antibodies 3 HIGH March 28, 1997
2276 4335 Apotex Cardiolipin ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2277 7145 BioHyTech EIA Kit 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2278 7244 Biopool Imulyse ACA 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2279 K992440 10497 Cogent Diagnostics AUTOSTAT II Anti-Cardiolipin IgG 434 Anti-Cardiolipin Antibodies 3 HIGH January 7, 2000
2280 K992449 10496 Cogent Diagnostics AUTOSTAT II Anti-Cardiolipin IgM 434 Anti-Cardiolipin Antibodies 3 HIGH January 7, 2000
2282 22208 GenBio ImmunoWELL Cardiolipin Ab (IgG) Test 434 Anti-Cardiolipin Antibodies 3 HIGH August 1, 1997
2283 22207 GenBio ImmunoWELL Cardiolipin Ab (IgM) Test 434 Anti-Cardiolipin Antibodies 3 HIGH August 1, 1997
2284 22119 General Biometrics ImmunoWELL Cardiolipin Ab (IgG) Test 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2285 22118 General Biometrics ImmunoWELL Cardiolipin Ab (IgM) Test 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2286 K932373 25150 Hemagen Cardiolipin Antibody Kit 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1993
2287 K971039 25276 Hemagen antiCardiolipin Screen Kit 434 Anti-Cardiolipin Antibodies 3 HIGH July 18, 1997
2291 K933784 28329 IMMCO Diagnostics Anti-Cardiolipin IgA Antibody (ACA) Test 434 Anti-Cardiolipin Antibodies 3 HIGH March 17, 1995
2292 K933788 28327 IMMCO Diagnostics Anti-Cardiolipin IgM Antibody (ACA) Test 434 Anti-Cardiolipin Antibodies 3 HIGH March 17, 1995
2293 K970177 28515 IMMCO Diagnostics ImmuLisa Anti-Cardiolipin Ab (ACA) Screen 434 Anti-Cardiolipin Antibodies 3 HIGH January 23, 1998
2294 K923320 28234 INOVA Diagnostics QUANTA Lite ACA Screen 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1993
2295 K953291 28406 INOVA Diagnostics QUANTA Lite ACA Screen (HRP) 434 Anti-Cardiolipin Antibodies 3 HIGH September 15, 1995
2296 K922351 28233 INOVA Diagnostics QUANTA Lite IgA ACA 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1993
2297 K953366 28407 INOVA Diagnostics QUANTA Lite IgA ACA (HRP) 434 Anti-Cardiolipin Antibodies 3 HIGH September 15, 1995
2298 K946034 28403 INOVA Diagnostics QUANTA Lite IgG ACA (HRP) 434 Anti-Cardiolipin Antibodies 3 HIGH July 28, 1995
2299 K946385 28386 INOVA Diagnostics QUANTA Lite IgM ACA 434 Anti-Cardiolipin Antibodies 3 HIGH July 28, 1995
2300 28143 Immuno Concepts Anti-cardiolipin Ab Semi-quantative Test System 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2301 K932225 28280 Immuno Concepts Anticardiolipin Ab Screening Test System 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1993
2302 K946216 28389 Immuno Probe Cardiolipin A EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 2, 1996
2303 K946215 28437 Immuno Probe Cardiolipin G EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 16, 1996
2304 K951363 28405 Immuno Probe Cardiolipin G,M,A EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 23, 1996
2305 K946217 28388 Immuno Probe Cardiolipin M EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 2, 1996
2306 K933588 37071 Louisville APL Diagnostics ApHL ELISA Kit 434 Anti-Cardiolipin Antibodies 3 HIGH October 28, 1994
2307 K952523 40245 MarDx Cardiolipin IgG EIA 434 Anti-Cardiolipin Antibodies 3 HIGH March 1, 1996
2308 K952520 40244 MarDx Cardiolipin IgG,M,A EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 16, 1996
2309 K952521 40246 MarDx Cardiolipin IgM EIA 434 Anti-Cardiolipin Antibodies 3 HIGH March 1, 1996
2310 55013 Reaads Medical Products Anti-cardiolipin Semi-quantitative Test 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2311 58001 Sanofi/Kallestad Anti-cardiolipin Kit EIA 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2312 K923886 58295 Shield Diagnostics DIASTAT Total Anti-Cardiolipin Kit 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1993
2313 K955303 58422 Shield Diagnostics DIASTAT anti-Cardiolipin IgG/IgM (qualitative) 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1996
2314 K955303 58421 Shield Diagnostics DIASTAT anti-Cardiolipin IgG/IgM (quantitative) 434 Anti-Cardiolipin Antibodies 3 HIGH November 22, 1996
2318 58178 Sigma Diagnostics SIA Anti-Cardiolipin 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2319 K983696 61384 The Binding Site BINDAZYME Anticardiolipin IgA EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 12, 1999
2320 K983695 61381 The Binding Site BINDAZYME Anticardiolipin IgGAM Screen EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 12, 1999
2321 K983694 61382 The Binding Site BINDAZYME Anticardiolipin IgM EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 12, 1999
2322 61017 TheraTest Laboratories EL-ACA Test 434 Anti-Cardiolipin Antibodies 3 HIGH July 26, 1993
2323 K981020 79060 Zeus Scientific Cardiolipin IgA ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH September 11, 1998
2324 K981014 79062 Zeus Scientific Cardiolipin IgG ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH September 11, 1998
2325 K971784 79063 Zeus Scientific Cardiolipin IgG/IgM ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH September 11, 1998
2326 K981021 79061 Zeus Scientific Cardiolipin IgM ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH September 11, 1998
2327 K935288 16055 elias usa Synelisa Cardiolipin Abs (IgA) 434 Anti-Cardiolipin Antibodies 3 HIGH June 10, 1994
2328 K933393 16056 elias usa Synelisa Cardiolipin Abs (IgG) 434 Anti-Cardiolipin Antibodies 3 HIGH June 10, 1994
2329 K933392 16057 elias usa Synelisa Cardiolipin Abs (IgM) 434 Anti-Cardiolipin Antibodies 3 HIGH June 10, 1994
2330 K951187 16122 elias usa Varelisa Cardiolipin Abs Screen 434 Anti-Cardiolipin Antibodies 3 HIGH January 26, 1996
2331 K940403 16066 elias usa elias Cardiolipin (IgA) Abs EIA (qualitative) 434 Anti-Cardiolipin Antibodies 3 HIGH October 14, 1994
2332 K940403 16067 elias usa elias Cardiolipin (IgA) Abs EIA (semi-quantitative) 434 Anti-Cardiolipin Antibodies 3 HIGH October 14, 1994
2333 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 487 Anti-Centromere Antibodies 3 HIGH December 22, 1999
2334 K932877 58423 Shield Diagnostics DIASTAT Anti-Centromere Kit (qualitative) 487 Anti-Centromere Antibodies 3 HIGH November 22, 1996
2335 K932877 58312 Shield Diagnostics DIASTAT Anti-Centromere Kit (semi-quantitative) 487 Anti-Centromere Antibodies 3 HIGH November 22, 1996
2336 K931255 16047 elias usa Synelisa Centromere Abs 487 Anti-Centromere Antibodies 3 HIGH May 20, 1994
2337 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 487 Anti-Centromere Antibodies 3 HIGH October 14, 1994
2338 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 487 Anti-Centromere Antibodies 3 HIGH October 14, 1994
2339 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 487 Anti-Centromere Antibodies 3 HIGH April 28, 1995
2340 K944171 16085 elias usa Varelisa Centromere Antibodies (qualitative) 487 Anti-Centromere Antibodies 3 HIGH January 6, 1995
2341 K944171 16086 elias usa Varelisa Centromere Antibodies (semi-quantitative) 487 Anti-Centromere Antibodies 3 HIGH January 6, 1995
2342 K982603 28537 INOVA Diagnostics QUANTA Lite Chromatin ELISA 542 Anti-Chromatin Antibodies 3 HIGH November 6, 1998
2343 K953671 4649 ALPCO ORGenTec Anti-dsDNA ELISA 435 Anti-DNA Antibodies 3 HIGH January 26, 1996
2344 K952055 4623 ALPCO ORGenTec Anti-dsDNA Pin Immuno Assay 435 Anti-DNA Antibodies 3 HIGH July 28, 1995
2345 4221 Antibodies Inc. CrithiDNA Test Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2346 4321 Apotex dsDNA ELISA 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2347 4707 Arlington Scientific dsDNA ELISA 435 Anti-DNA Antibodies 3 HIGH April 18, 1997
2348 7113 Behring AFT System II 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2349 7145 BioHyTech EIA Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2350 7239 BioWhittaker RheumELISA Plus Microwell Assay 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2351 7353 BioWhittaker dsDNA STAT 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2352 K922241 10206 Cambridge Life Sciences AUTOZYME 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2353 K940700 10263 Cambridge Life Sciences AUTOZYME Screen 435 Anti-DNA Antibodies 3 HIGH September 15, 1994
2354 K940585 10264 Cambridge Life Sciences SELISA Anti-nDNA Ab Kit 435 Anti-DNA Antibodies 3 HIGH September 15, 1994
2355 K923537 10238 Clark Laboratories Encore dsDNA EIA Test 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2356 K952567 10321 Cogent Diagnostics AUTOSTAT II Anti-dsDNA IgG (semi-quantitative) 435 Anti-DNA Antibodies 3 HIGH March 7, 1997
2357 13112 Diagnostic Products Corp. Solid Phase 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2358 13235 Diamedix Anti-dsDNA Microassay 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2359 K974694 13534 Diamedix Immunosimplicity (Is)-dsDNA (manual) 435 Anti-DNA Antibodies 3 HIGH October 16, 1998
2361 13217 Du Pont RIANIN Anti-dsDNA RIA Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2363 22213 GenBio ImmunoWELL dsDNA Ab Test 435 Anti-DNA Antibodies 3 HIGH August 1, 1997
2365 22124 General Biometrics ImmunoWELL dsDNA Ab Test 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2366 K913041 25171 Helix Diagnostics Anti-dsDNA EIA 435 Anti-DNA Antibodies 3 HIGH November 10, 1994
2367 25011 Hemagen DNA 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2368 K962276 25265 Hemagen DNA Kit (EIA method) 435 Anti-DNA Antibodies 3 HIGH January 17, 1997
2370 K964165 28477 IMI MICRO21 {Immuno Concepts Colorzyme nDNA} 435 Anti-DNA Antibodies 3 HIGH April 4, 1997
2371 K921658 28276 IMMCO Diagnostics Anti-dsDNA Antibody Test 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2372 K884400 28312 IMMCO Diagnostics Anti-native DNA Antibody Test 435 Anti-DNA Antibodies 3 HIGH September 1, 1994
2373 K954380 28436 INOVA Diagnostics QUANTA Lite ssDNA SemiQuantative ELISA 435 Anti-DNA Antibodies 3 HIGH March 8, 1996
2374 28132 Immuno Concepts Colorzyme nDNA Test System 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2375 28138 Immuno Concepts Fluorescent nDNA Ab Test System 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2376 28050 Incstar nDNA Fluoro-Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2377 K960182 40253 MarDx Anti-dsDNA (Immunoglobulin) EIA 435 Anti-DNA Antibodies 3 HIGH May 10, 1996
2378 40023 MeDiCa A-nDNA-A Test Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2379 40026 MeDiCa ANA/A-nDNA-A Test Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2380 40031 MeDiCa Multiple Antibody Test Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2381 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 435 Anti-DNA Antibodies 3 HIGH December 22, 1999
2382 K980391 52077 Quest International SeraQuest Anti-dsDNA (manual/qualitative) 435 Anti-DNA Antibodies 3 HIGH May 22, 1998
2383 K980391 52078 Quest International SeraQuest Anti-dsDNA (manual/semi-quantitative) 435 Anti-DNA Antibodies 3 HIGH May 22, 1998
2385 K980391 52080 Quest International SeraQuest Anti-dsDNA {Hyperion HyPrep Plus} (manual calculations) 435 Anti-DNA Antibodies 3 HIGH May 22, 1998
2386 55014 Reaads Medical Products Anti-ds DNA Semi-quantitative Test 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2387 58011 Sanofi/Kallestad Quantifluor Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2388 58030 Scimedx nDNA Test System 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2390 K943291 58346 Sigma Diagnostics Anti-dsDNA Kit 435 Anti-DNA Antibodies 3 HIGH December 9, 1994
2391 58211 Sigma Diagnostics SIA Anti-DNA 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2393 K990916 58593 Stellar Bio Systems Indirect Fluorescence Assay for Anti-native DNA IgG 435 Anti-DNA Antibodies 3 HIGH December 22, 1999
2394 K993727 61461 The Binding Site BINDAZYME Anti-dsDNA EIA 435 Anti-DNA Antibodies 3 HIGH January 7, 2000
2395 K930247 61112 The Binding Site BINDAZYME a-dsDNA EIA 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2396 K930987 61109 The Binding Site Crithidia luciliae dsDNA 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2397 K955481 61243 TheraTest Laboratories EL-ANA Profiles (anti-dsDNA) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2398 K955481 61242 TheraTest Laboratories EL-ANA Profiles (anti-ssDNA) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2399 K955481 61239 TheraTest Laboratories EL-ANA Profiles (anti-ssDNA, -dsDNA) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2400 61018 TheraTest Laboratories EL-ANA Profiles Test 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2401 K955481 61235 TheraTest Laboratories EL-ANA/6 (ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2402 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2403 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2404 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 435 Anti-DNA Antibodies 3 HIGH July 19, 1996
2405 67017 Virgo Anti-nDNA IFA Test 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
2406 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 435 Anti-DNA Antibodies 3 HIGH June 10, 1994
2407 K921132 16019 elias usa Synelisa dsDNA Antibodies 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2408 K944334 16107 elias usa Varelisa Combined DNA Antibodies 435 Anti-DNA Antibodies 3 HIGH April 28, 1995
2409 K950031 16100 elias usa Varelisa dsDNA Antibodies (FARR version) 435 Anti-DNA Antibodies 3 HIGH March 17, 1995
2410 K930421 16031 elias usa elias dsDNA Abs EIA Kit 435 Anti-DNA Antibodies 3 HIGH November 22, 1993
2413 7145 BioHyTech EIA Kit 436 Anti-DNP Antibodies 3 HIGH July 26, 1993
2415 13236 Diamedix Anti-DNP Microassay 436 Anti-DNP Antibodies 3 HIGH July 26, 1993
2420 58212 Sigma Diagnostics SIA Anti-DNP 436 Anti-DNP Antibodies 3 HIGH July 26, 1993
2423 K955134 4650 ALPCO ORGenTec ENAScreen (SS-A,SS-B,Sm,RNP/Sm,Scl-70,Jo1) 507 Anti-ENA Antibodies 3 HIGH April 19, 1996
2424 K955133 4656 ALPCO ORGenTec ENAscreen Pin Immuno Assay 507 Anti-ENA Antibodies 3 HIGH April 19, 1996
2426 K983921 10478 Cogent Diagnostics AUTOSTAT II Anti-ENA-6 Screen (IgG) ELISA (SS-A/Ro,SS-B/La,Sm,Sm/RNP,Jo-1,Scl-70) 507 Anti-ENA Antibodies 3 HIGH July 9, 1999
2427 K980759 13506 Diamedix Immunosimplicity (Is)-ENA-6 (Sm,Sm/RNP,SSA,SSB,Scl-70,Jo-1) (manual) 507 Anti-ENA Antibodies 3 HIGH August 28, 1998
2429 K952253 25241 Helix Diagnostics ENA+Screen (RNP,Sm,SS-A,SS-B,Scl-70,Jo-1) 507 Anti-ENA Antibodies 3 HIGH September 8, 1995
2430 K952076 25228 Hemagen ENA Screen 4 Kit (RNP, Sm, SS-A, SS-B) 507 Anti-ENA Antibodies 3 HIGH June 30, 1995
2431 K952077 25229 Hemagen ENA Screen 6 Kit (RNP, Sm, SS-A, SS-B, Scl-70,Jo-1) 507 Anti-ENA Antibodies 3 HIGH June 30, 1995
2433 K943076 28365 INOVA Diagnostics QUANTA Lite ENA 5 ELISA (Sm,RNP,SS-A,SS-B,Scl-70) 507 Anti-ENA Antibodies 3 HIGH December 9, 1994
2434 K961913 28465 INOVA Diagnostics QUANTA Lite ENA 6 ELISA (Sm,RNP,SSA,SSB,Scl-70,Jo-1) 507 Anti-ENA Antibodies 3 HIGH November 22, 1996
2435 K963275 28467 Immuno Concepts RELISA Single Well (RNP,Sm,SS-A,SS-B,Scl-70,Jo1) 507 Anti-ENA Antibodies 3 HIGH December 6, 1996
2436 K946218 40212 MarDx ENA EIA Test Kit 507 Anti-ENA Antibodies 3 HIGH June 23, 1995
2437 K944505 58345 Shield Diagnostics DIASTAT ENA Single Well Screen Kit 507 Anti-ENA Antibodies 3 HIGH December 9, 1994
2439 K982150 61376 TheraTest Laboratories EL-ANA PROFILES: EL-ENA/4 (Sm, RNP, SS-A, SS-B) 507 Anti-ENA Antibodies 3 HIGH November 6, 1998
2440 K982622 61375 TheraTest Laboratories EL-ANA PROFILES: EL-ENA/5 (Sm, RNP, SS-A, SS-B, Scl-70) 507 Anti-ENA Antibodies 3 HIGH November 6, 1998
2441 K935413 70226 Wampole ENA EIA (Sm,RNP,Ro,La,Scl-70,Jo-1) 507 Anti-ENA Antibodies 3 HIGH July 31, 1998
2442 K941014 79044 Zeus Scientific ENA Screen ELISA 507 Anti-ENA Antibodies 3 HIGH October 14, 1994
2443 K912551 28281 IMMCO Diagnostics Anti-Endomysial Antibody (EMA) Test 497 Anti-Endomysial Antibodies (EMA) 3 HIGH November 22, 1993
2444 K980312 28527 INOVA Diagnostics NOVA Lite Endomysial Antibody 497 Anti-Endomysial Antibodies (EMA) 3 HIGH July 10, 1998
2445 K993034 40335 MeDiCa AEmA Test Kit 497 Anti-Endomysial Antibodies (EMA) 3 HIGH November 19, 1999
2446 K981209 61358 The Binding Site Monkey Oesophagus IFA 497 Anti-Endomysial Antibodies (EMA) 3 HIGH October 30, 1998
2447 K993086 10492 Cogent Diagnostics AUTOSTAT II Anti-Gliadin IgA 528 Anti-Gliadin Antibodies 3 HIGH December 10, 1999
2448 K993087 10489 Cogent Diagnostics AUTOSTAT II Anti-Gliadin IgG 528 Anti-Gliadin Antibodies 3 HIGH December 10, 1999
2449 K973910 22257 Genesis Diagnostics Anti-Gliadin Antibodies (AGA) ELISA (semi-quantitative) 528 Anti-Gliadin Antibodies 3 HIGH April 16, 1999
2452 K964341 28514 IMMCO Diagnostics ImmuLisa Anti-Gliadin Ab (AGA) (semi-quantitative) 528 Anti-Gliadin Antibodies 3 HIGH January 23, 1998
2453 K964986 28482 INOVA Diagnostics QUANTA Lite IgA Gliadin ELISA 528 Anti-Gliadin Antibodies 3 HIGH June 27, 1997
2454 K964985 28481 INOVA Diagnostics QUANTA Lite IgG Gliadin ELISA 528 Anti-Gliadin Antibodies 3 HIGH June 27, 1997
2458 K981929 61360 The Binding Site BINDAZYME Antigliadin IgA 528 Anti-Gliadin Antibodies 3 HIGH September 11, 1998
2459 K981644 61359 The Binding Site BINDAZYME Antigliadin IgG 528 Anti-Gliadin Antibodies 3 HIGH September 11, 1998
2460 K981644 61361 The Binding Site BINDAZYME Antigliadin IgG/IgA Combi 528 Anti-Gliadin Antibodies 3 HIGH September 11, 1998
2461 K984137 28555 INOVA Diagnostics QUANTA Lite Celiac Screen ELISA (IgA) 544 Anti-Gliadin/Tissue Transglutaminase (tTG) 3 HIGH April 2, 1999
2462 K991890 10486 Cogent Diagnostics AUTOSTAT II Anti-GBM 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH November 1, 1999
2463 K971464 16190 Euro-Diagnostica Immunoscan Anti-GMB 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH April 10, 1998
2464 K991890 25302 Hycor HY-TEC Anti-GBM ELISA (manual) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH November 1, 1999
2466 K984336 28554 INOVA Diagnostics QUANTA Lite GBM ELISA (IgG) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH April 2, 1999
2467 K953495 58409 Scimedx GMB Antibody (manual calculations) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH May 17, 1996
2468 K963525 58427 Shield Diagnostics DIASTAT anti-GBM (qualitative) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH December 2, 1996
2469 K963525 58426 Shield Diagnostics DIASTAT anti-GBM (semi-quantitative) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH December 2, 1996
2470 K984619 61385 The Binding Site BINDAZYME Anti-GMB EIA (qualitative) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH March 12, 1999
2471 K984619 61386 The Binding Site BINDAZYME Anti-GMB EIA (quantitative) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH March 12, 1999
2472 K974169 70221 Wieslab AB Wielisa anti-GBM Test 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH May 15, 1998
2473 K981750 70227 Wieslab AB Wielisa anti-GBM, ANCA Screening Kit 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH October 16, 1998
2474 4329 Apotex Histone ELISA 437 Anti-Histone Antibodies 3 HIGH July 26, 1993
2475 4709 Arlington Scientific Histone ELISA 437 Anti-Histone Antibodies 3 HIGH April 18, 1997
2476 7145 BioHyTech EIA Kit 437 Anti-Histone Antibodies 3 HIGH July 26, 1993
2477 K932679 7488 BioWhittaker RheumELISA II 437 Anti-Histone Antibodies 3 HIGH November 22, 1993
2478 K940700 10263 Cambridge Life Sciences AUTOZYME Screen 437 Anti-Histone Antibodies 3 HIGH September 15, 1994
2479 K943585 28354 IMMCO Diagnostics ImmuLisa Anti-Histone Ab ELISA 437 Anti-Histone Antibodies 3 HIGH February 3, 1995
2480 K934053 28332 INOVA Diagnostics QUANTA Lite Histone ELISA 437 Anti-Histone Antibodies 3 HIGH June 10, 1994
2481 K955481 61249 TheraTest Laboratories EL-ANA Profiles (anti-Histone) 437 Anti-Histone Antibodies 3 HIGH July 19, 1996
2482 K950716 61018 TheraTest Laboratories EL-ANA Profiles Test 437 Anti-Histone Antibodies 3 HIGH October 6, 1995
2483 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 437 Anti-Histone Antibodies 3 HIGH July 19, 1996
2484 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 437 Anti-Histone Antibodies 3 HIGH July 19, 1996
2485 K940253 70224 Wampole Histone EIA 437 Anti-Histone Antibodies 3 HIGH July 31, 1998
2486 K932302 16041 elias usa Synelisa Histone Antibodies EIA Kit 437 Anti-Histone Antibodies 3 HIGH November 22, 1993
2487 K951207 16106 elias usa Varelisa Histone Antibodies (qualitative) 437 Anti-Histone Antibodies 3 HIGH April 28, 1995
2488 K951207 16105 elias usa Varelisa Histone Antibodies (semi-quantitative) 437 Anti-Histone Antibodies 3 HIGH April 28, 1995
2489 K954829 4653 ALPCO ORGenTec Anti-JO-1 Pin Immuno Assay 438 Anti-Jo-1 3 HIGH April 26, 1996
2490 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 438 Anti-Jo-1 3 HIGH November 22, 1993
2491 K924950 4503 Advanced Biological Products ELISA-DOXA JO-1 438 Anti-Jo-1 3 HIGH November 22, 1993
2492 4362 Apotex Jo-1 ELISA 438 Anti-Jo-1 3 HIGH July 26, 1993
2493 4710 Arlington Scientific Jo-1 ELISA 438 Anti-Jo-1 3 HIGH April 18, 1997
2494 K930757 7488 BioWhittaker RheumELISA II 438 Anti-Jo-1 3 HIGH November 22, 1993
2495 K922241 10206 Cambridge Life Sciences AUTOZYME 438 Anti-Jo-1 3 HIGH November 22, 1993
2496 K990798 10474 Cogent Diagnostics AUTOSTAT II Anti-Jo-1 (IgG) ELISA 438 Anti-Jo-1 3 HIGH July 9, 1999
2497 13230 Diamedix Anti-Jo-1 Microassay 438 Anti-Jo-1 3 HIGH July 26, 1993
2498 K970228 13537 Diamedix Immunosimplicity (Is)-anti-Jo-1 (manual) 438 Anti-Jo-1 3 HIGH October 16, 1998
2500 K951850 25231 Helix Diagnostics Anti-Jo-1 EIA 438 Anti-Jo-1 3 HIGH July 28, 1995
2501 25012 Hemagen ENA 438 Anti-Jo-1 3 HIGH July 26, 1993
2502 K935828 25160 Hemagen ENA Screen 6 Kit 438 Anti-Jo-1 3 HIGH September 30, 1994
2503 K946124 25190 Hemagen Jo-1 ENA Kit (qualitative) 438 Anti-Jo-1 3 HIGH March 3, 1995
2504 K946124 25195 Hemagen Jo-1 ENA Kit (semi-quantitative) 438 Anti-Jo-1 3 HIGH March 3, 1995
2505 K926562 28273 INOVA Diagnostics QUANTA Lite Jo-1 ELISA 438 Anti-Jo-1 3 HIGH November 22, 1993
2506 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 438 Anti-Jo-1 3 HIGH June 10, 1994
2507 K955605 28449 Immuno Concepts RELISA Jo-1 438 Anti-Jo-1 3 HIGH August 9, 1996
2508 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 438 Anti-Jo-1 3 HIGH August 1, 1997
2509 K935417 40182 Molecular Immunodiagnostics Jo-1 EIA Test Kit 438 Anti-Jo-1 3 HIGH June 10, 1994
2510 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 438 Anti-Jo-1 3 HIGH December 22, 1999
2512 K924262 61114 The Binding Site ENA Screening CIE 438 Anti-Jo-1 3 HIGH November 22, 1993
2513 K955481 61250 TheraTest Laboratories EL-ANA Profiles (anti-Jo-1) 438 Anti-Jo-1 3 HIGH July 19, 1996
2515 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 438 Anti-Jo-1 3 HIGH January 18, 2000
2516 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 438 Anti-Jo-1 3 HIGH October 14, 1994
2517 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 438 Anti-Jo-1 3 HIGH June 10, 1994
2518 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 438 Anti-Jo-1 3 HIGH October 14, 1994
2519 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 438 Anti-Jo-1 3 HIGH October 14, 1994
2520 K930281 16038 elias usa Synelisa Jo-1 Antibodies EIA Kit 438 Anti-Jo-1 3 HIGH November 22, 1993
2521 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 438 Anti-Jo-1 3 HIGH April 28, 1995
2522 K944173 16081 elias usa Varelisa Jo-1 Antibodies (qualitative) 438 Anti-Jo-1 3 HIGH January 6, 1995
2523 K944173 16082 elias usa Varelisa Jo-1 Antibodies (semi-quantitative) 438 Anti-Jo-1 3 HIGH January 6, 1995
2524 4317 Apotex Mitochondral ELISA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2525 4708 Arlington Scientific Mitochondrial ELISA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH April 18, 1997
2526 7112 Behring AFT System I 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2527 K971909 25275 Hemagen VIRGO AMA EIA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 18, 1997
2528 28311 IMMCO Diagnostics Autoantibody Test System 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH September 1, 1994
2529 K933180 28270 INOVA Diagnostics QUANTA Lite Mitochondria M2 ELISA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH November 22, 1993
2530 28042 Incstar Fluoro-Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2531 K950110 40211 MarDx Mitochondria EIA Test Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH June 23, 1995
2532 40016 MarDx Mitochondrial Antibodies Test System 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2533 40031 MeDiCa Multiple Antibody Test Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2534 58011 Sanofi/Kallestad Quantifluor Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2535 58016 Scimedx Auto Screen Test System 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2536 58026 Scimedx MA Test System 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2537 K971658 61290 The Binding Site Mouse Liver, Kidney, Stomach IFA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH June 13, 1997
2538 K955431 61254 The Binding Site Rat Liver, Kidney, Stomach IFA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH September 6, 1996
2539 67015 Virgo AMA IFA Test 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2540 K940251 70225 Wampole Mitochondria EIA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 31, 1998
2541 79032 Zeus Scientific Autoantibody Screen (AAS) 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2542 79018 Zeus Scientific MA 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
2543 K930143 16036 elias usa Synelisa M2 Antibodies EIA Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH November 22, 1993
2544 K974701 4790 ALPCO ORGenTec Anti-MPO (p-ANCA) ELISA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH May 15, 1998
2545 K983390 13587 Diamedix Immunosimplicity (Is)-MPO (P-ANCA) IgG (manual/qualitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH November 19, 1999
2546 K983390 13588 Diamedix Immunosimplicity (Is)-MPO (P-ANCA) IgG (manual/semi-quantitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH November 19, 1999
2548 K971689 16188 Euro-Diagnostica Immunoscan MPO-ANCA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH April 10, 1998
2549 K973824 25284 Hemagen VIRGO pANCA EIA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH February 6, 1998
2550 K981330 28530 INOVA Diagnostics QUANTA Lite MPO IgG ELISA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH August 14, 1998
2551 K954062 58405 Scimedx MPO Antibody (auto reader w/data reduction) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH April 5, 1996
2552 K954062 58404 Scimedx MPO Antibody (manual) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH April 5, 1996
2553 K943630 58331 Shield Diagnostics DIASTAT Anti-MPO (qualitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH March 10, 1995
2554 K943630 58332 Shield Diagnostics DIASTAT Anti-MPO (semi-quantitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH March 10, 1995
2556 K981030 61350 The Binding Site BINDAZYME Anti-MPO EIA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH July 31, 1998
2557 K961765 70191 Wampole MPO IgG,A,M ELISA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH November 15, 1996
2558 K981748 70228 Wieslab AB Wielisa ANCA Screening Kit 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH October 16, 1998
2559 K974166 70223 Wieslab AB Wielisa MPO ANCA Test 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH May 15, 1998
2560 K981750 70227 Wieslab AB Wielisa anti-GBM, ANCA Screening Kit 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH October 16, 1998
2561 K964446 79057 Zeus Scientific Myeloperoxidase IgG ELISA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH July 25, 1997
2562 K953586 16130 elias usa Varelisa MPO-ANCA EIA (qualitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH March 8, 1996
2563 K953586 16129 elias usa Varelisa MPO-ANCA EIA (semi-quantitative) 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH March 8, 1996
2564 K973822 25282 Hemagen VIRGO ANCA Screen EIA 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH February 6, 1998
2565 K982898 28549 IMMCO Diagnostics ImmuGlo Anti-Neutrophil Cytoplasmic Antibody (ANCA) 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH March 26, 1999
2566 K961340 28463 INOVA Diagnostics NOVA Lite ANCA 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH November 15, 1996
2567 58014 Scimedx Anti-Neutrophil Cytoplasm Antibodies IFA Test 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH July 26, 1993
2568 K962360 58419 Scimedx Anti-Neutrophil Cytoplasmic Ab (ANCA) IFA 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH November 22, 1996
2570 K965133 61291 The Binding Site ANCA Combi Kit 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH June 20, 1997
2571 K964449 79058 Zeus Scientific ANCA Screen ELISA 440 Anti-Neutrophil Cytoplasm Antibodies (ANCA) 3 HIGH July 25, 1997
2572 4157 Amico ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2573 4220 Antibodies Inc. Antinuclear Antibody (ANA) Test Kit (FA) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2575 7243 Behring AFT System HEp 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2576 7112 Behring AFT System I 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2578 7328 BioWhittaker FIAX System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2580 7153 Bion ANA Test Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2581 10065 Clinical Sciences ANAFLUOR 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2582 K983655 10476 Cogent Diagnostics AUTOSTAT II ANA Screen (IgG) ELISA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 9, 1999
2586 K954723 25294 Helix Diagnostics Antinuclear Antibody Screen EIA (dsDNA,Histone,SSA,SSB,Sm,SmRNP,Scl-70,Jo-1,Centromere) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 19, 1999
2587 25010 Hemagen ANA System (FA) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2588 K960774 28447 IMI MICRO21 {Immuno Concepts Colorzyme ANA} 441 Anti-Nuclear Antibodies (ANA) 3 HIGH August 16, 1996
2589 K883915 28311 IMMCO Diagnostics Autoantibody Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH September 1, 1994
2590 28001 INOVA Diagnostics NOVA Lite ANA (IFA) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2591 K991657 28564 INOVA Diagnostics QUANTA Lite ANA ELISA (dsDNA,Histone,Sm/RNP,SSA,SSB,Scl-70,Centromere,PCNA,Jo-1,M-2,Ribosomal-P) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 19, 1999
2592 K922829 28235 INOVA Diagnostics QUANTA Lite ENA 4 ELISA (Sm,RNP,SS-A,SS-B) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH November 22, 1993
2593 28131 Immuno Concepts Colorzyme ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2594 28024 Immuno Concepts Fluorescent ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2595 K944096 28366 Immuno Concepts HEp-2000 Fluorescent ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH December 9, 1994
2596 K992041 28565 Immuno Concepts RELISA ANA Screening Test 441 Anti-Nuclear Antibodies (ANA) 3 HIGH August 12, 1999
2597 28035 Incstar ANA Colorimetric Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2598 28036 Incstar ANAFAST Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2599 28037 Incstar ANAFLUOR Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2600 28038 Incstar ANAZYME Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2601 28042 Incstar Fluoro-Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2602 28049 Incstar RL Fluoro-Kit ANA Fluorescent test 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2604 K944191 37097 Light Diagnostics ANA Test Kit with Mouse Liver Substrate 441 Anti-Nuclear Antibodies (ANA) 3 HIGH March 10, 1995
2605 40004 MarDx ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2606 40008 MarDx Autoimmune IFA Screening Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2607 40025 MeDiCa ANA Test Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2608 40026 MeDiCa ANA/A-nDNA-A Test Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2609 40031 MeDiCa Multiple Antibody Test Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2610 46069 Ortho Fluoroset ANA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2611 K993108 49228 Pharmacia & Upjohn Varelisa ReCombi ANA Screen (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH December 22, 1999
2612 52001 Quidel ANA IFA kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2613 K914853 55302 Reaads Medical Products Antinuclear Antibody (ANA) Test Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH September 25, 1998
2614 K994071 55670 RhiGene ANA ELISA TEST SYSTEM 441 Anti-Nuclear Antibodies (ANA) 3 HIGH January 26, 2000
2615 K952490 55199 Roche Diagnostics Image Titer (RIAS) Antinuclear Antibody (ANA) Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH March 1, 1996
2616 58011 Sanofi/Kallestad Quantifluor Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2617 58012 Scimedx ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2618 58016 Scimedx Auto Screen Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2619 K970198 58453 Scimedx HEp2 ANA IFA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 25, 1997
2620 K932876 58313 Shield Diagnostics Anti-Nuclear Antibody (ANA) Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH May 20, 1994
2622 K990915 58592 Stellar Bio Systems Indirect Fluorescence Assay for IgG ANA HEp2 441 Anti-Nuclear Antibodies (ANA) 3 HIGH December 22, 1999
2623 K926114 61296 The Binding Site HEp2 Cell ANA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH October 3, 1997
2624 K971658 61290 The Binding Site Mouse Liver, Kidney, Stomach IFA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH June 13, 1997
2625 K955431 61254 The Binding Site Rat Liver, Kidney, Stomach IFA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH September 6, 1996
2626 K954106 61220 TheraTest Laboratories EL-ANAscr 441 Anti-Nuclear Antibodies (ANA) 3 HIGH December 8, 1995
2627 K926114 61108 Tissue Culture Biotec ANA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH November 22, 1993
2628 67016 Virgo ANA IFA Test 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2629 79001 Zeus Scientific ANA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2630 79033 Zeus Scientific ANA HEp-2 Cell Culture IFA Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2631 K940362 79043 Zeus Scientific ANA Screen ELISA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH September 15, 1994
2632 79032 Zeus Scientific Autoantibody Screen (AAS) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
2633 K964385 16141 elias usa ANA HEp-2 441 Anti-Nuclear Antibodies (ANA) 3 HIGH May 23, 1997
2634 K940641 16063 elias usa ANA Total EIA Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH September 15, 1994
2635 K935468 16054 elias usa Synelisa ANA Total 441 Anti-Nuclear Antibodies (ANA) 3 HIGH June 10, 1994
2636 K940622 16071 elias usa Varelisa ANA-8 Screen (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH October 14, 1994
2637 K951186 16111 elias usa Varelisa ANA-Screen (4) (Sm,RNP-Sm,SS-A,SS-B) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH April 28, 1995
2638 K991942 10487 Cogent Diagnostics AUTOSTAT II Anti-GPC 442 Anti-Parietal Cell Antibodies 3 HIGH November 1, 1999
2639 K991942 25300 Hycor HY-TEC Anti-GPC ELISA (manual) 442 Anti-Parietal Cell Antibodies 3 HIGH November 1, 1999
2641 28311 IMMCO Diagnostics Autoantibody Test System 442 Anti-Parietal Cell Antibodies 3 HIGH September 1, 1994
2642 28042 Incstar Fluoro-Kit 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2643 40017 MarDx Parietal Cell Antibody Test System 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2644 40027 MeDiCa APCA Test Kit 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2645 40031 MeDiCa Multiple Antibody Test Kit 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2646 58011 Sanofi/Kallestad Quantifluor Kit 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2647 58016 Scimedx Auto Screen Test System 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2648 58027 Scimedx PCA Test System 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2649 K971658 61290 The Binding Site Mouse Liver, Kidney, Stomach IFA 442 Anti-Parietal Cell Antibodies 3 HIGH June 13, 1997
2650 K955431 61254 The Binding Site Rat Liver, Kidney, Stomach IFA 442 Anti-Parietal Cell Antibodies 3 HIGH September 6, 1996
2651 79032 Zeus Scientific Autoantibody Screen (AAS) 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
2652 K930422 16040 elias usa Synelisa Parietal Cell Antibodies EIA Kit 442 Anti-Parietal Cell Antibodies 3 HIGH November 22, 1993
2653 K951206 16108 elias usa Varelisa Parietal Cell Abs (semi-quantitative) 442 Anti-Parietal Cell Antibodies 3 HIGH April 28, 1995
2654 K952287 55186 Reaads Medical Products Anti-Phosphatidylserine Semi-Quantitative Test Kit 521 Anti-Phosphatidylserine Antibodies 3 HIGH January 19, 1996
2655 K952287 58186 Seragen Quick-Chem 521 Anti-Phosphatidylserine Antibodies 3 HIGH January 19, 1996
2656 K983379 22261 Genetic Testing Institute GTI-PF4 ELISA 545 Anti-Platelet Factor IV complex Antibodies 3 HIGH June 11, 1999
2657 K974702 4789 ALPCO ORGenTec Anti-PR3 (c-ANCA) ELISA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH May 15, 1998
2658 K990796 10477 Cogent Diagnostics AUTOSTAT II Anti-PR-3 c-ANCA (IgG) ELISA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH July 9, 1999
2659 K983740 13584 Diamedix Immunosimplicity (Is)-anti-PR-3 (C-ANCA) IgG (manual/qualitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH November 19, 1999
2660 K983740 13585 Diamedix Immunosimplicity (Is)-anti-PR-3 (C-ANCA) IgG (manual/semi-quantitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH November 19, 1999
2662 K971690 16189 Euro-Diagnostica Immunoscan PR3-ANCA (anti-PR3 specific) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH April 10, 1998
2663 K973823 25283 Hemagen VIRGO cANCA EIA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH February 6, 1998
2664 K990796 25293 Hycor HY-TEC Anti-PR-3 c-ANCA (IgG) ELISA (manual) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH July 9, 1999
2666 K954105 58386 Scimedx Anti-PR3 Antibody EIA (computer calculations) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH March 22, 1996
2667 K954105 58385 Scimedx Anti-PR3 Antibody EIA (manual calculations) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH March 22, 1996
2668 K942813 58424 Shield Diagnostics DIASTAT Anti-PR3 (cANCA) (qualitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH November 22, 1996
2670 K981029 61349 The Binding Site BINDAZYME Anti-PR3 EIA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH July 31, 1998
2671 K961764 70190 Wampole PR-3 IgG,A,M ELISA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH November 15, 1996
2672 K981748 70228 Wieslab AB Wielisa ANCA Screening Kit 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH October 16, 1998
2673 K974167 70222 Wieslab AB Wielisa PR-3 ANCA Test 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH May 15, 1998
2674 K981750 70227 Wieslab AB Wielisa anti-GBM, ANCA Screening Kit 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH October 16, 1998
2675 K964448 79054 Zeus Scientific Proteinase-3 IgG ELISA 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH July 25, 1997
2676 K953587 16124 elias usa Varelisa PR3-ANCA EIA (qualitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH February 9, 1996
2677 K924951 4505 Advanced Biological Products ELISA-DOXA Combi-4 (SS-A/Ro,SS-B/LA,Sm,RNP) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2678 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2679 K924948 4506 Advanced Biological Products ELISA-DOXA Sm/RNP Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2680 K932424 4507 Apotex ANA Profile I 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2681 4316 Apotex ENA Profile ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2682 4310 Apotex SM/RNP ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2683 K932424 4711 Arlington Scientific ANA Profile I ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH April 18, 1997
2684 4712 Arlington Scientific ENA Profile ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH April 18, 1997
2685 4713 Arlington Scientific Sm/RNP ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH April 18, 1997
2686 7114 Behring ENA I Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2688 7145 BioHyTech EIA Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2689 7345 BioWhittaker RheumELISA Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2690 7239 BioWhittaker RheumELISA Plus Microwell Assay 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2691 K922241 10206 Cambridge Life Sciences AUTOZYME 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2692 K940700 10263 Cambridge Life Sciences AUTOZYME Screen 443 Anti-RNP (Ribonucleoprotein) 3 HIGH September 15, 1994
2693 K931543 10255 Clark Laboratories ENA Combined Test Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH May 25, 1994
2694 K921870 10240 Clark Laboratories Encore Sm/RNP Antigen EIA Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2695 K990624 10471 Cogent Diagnostics AUTOSTAT II Anti-Sm/RNP (IgG) ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 9, 1999
2696 13237 Diamedix Anti-RNP Microassay 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2698 22206 GenBio ImmunoWELL RNP/Sm Ab Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH August 1, 1997
2700 22117 General Biometrics ImmunoWELL RNP/Sm Ab Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2701 K932850 25157 Helix Diagnostics Extractable Nuclear Antigen EIATest 443 Anti-RNP (Ribonucleoprotein) 3 HIGH May 20, 1994
2702 25012 Hemagen ENA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2703 K935828 25160 Hemagen ENA Screen 6 Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH September 30, 1994
2704 K920386 28317 IMMCO Diagnostics Anti-ENA Antibody Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH September 1, 1994
2705 K895338 28314 IMMCO Diagnostics Anti-RNP and Anti-Sm Antibody Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH September 1, 1994
2706 K922833 28236 INOVA Diagnostics QUANTA Lite RNP ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2707 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH June 10, 1994
2708 28126 Immuno Concepts Sm/RNP Ab Test System 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2709 34047 Kallestad Sm/RNP ENA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2710 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 443 Anti-RNP (Ribonucleoprotein) 3 HIGH August 1, 1997
2711 K935415 40184 Molecular Immunodiagnostics RNP EIA Test Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH June 10, 1994
2712 K993589 49223 Pharmacia & Upjohn Varelisa RNP Antibodies EIA (qualitative) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH December 10, 1999
2713 K993589 49224 Pharmacia & Upjohn Varelisa RNP Antibodies EIA (semi-quantitative) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH December 10, 1999
2714 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH December 22, 1999
2715 55011 Reaads Medical Products Anti-ENA (Sm/RNP complex) Qualitative Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2716 58019 Scimedx ENA Detect I Test System 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2717 58020 Scimedx ENA Detect II Test System 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2718 58021 Scimedx ENA Detect III Test System 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2719 58135 Shield Diagnostics DIASTAT ENA Profile Kit 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2720 K924262 61114 The Binding Site ENA Screening CIE 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
2721 61018 TheraTest Laboratories EL-ANA Profiles Test 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2722 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH June 10, 1994
2723 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH October 14, 1994
2724 79022 Zeus Scientific Poly-ENA 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 26, 1993
2725 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH October 14, 1994
2726 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH October 14, 1994
2727 K962057 4686 ALPCO ORGenTec Anti-RNP/Sm ELISA 502 Anti-RNP-Sm Antibodies 3 HIGH March 28, 1997
2728 K954831 4647 ALPCO ORGenTec Anti-RNP/Sm Pin Immuno Assay 502 Anti-RNP-Sm Antibodies 3 HIGH May 17, 1996
2730 K970238 13535 Diamedix Immunosimplicity (Is)-anti-Sm/RNP (manual) 502 Anti-RNP-Sm Antibodies 3 HIGH October 16, 1998
2732 K940588 25165 Helix Diagnostics Anti-Sm/RNP EIA 502 Anti-RNP-Sm Antibodies 3 HIGH October 14, 1994
2733 K950414 25189 Hemagen RNP-Sm ENA Kit (qualitative) 502 Anti-RNP-Sm Antibodies 3 HIGH April 7, 1995
2734 K950414 25194 Hemagen RNP-Sm ENA Kit (semi-quantitative) 502 Anti-RNP-Sm Antibodies 3 HIGH April 7, 1995
2736 K955604 28451 Immuno Concepts RELISA Sm/RNP 502 Anti-RNP-Sm Antibodies 3 HIGH August 9, 1996
2737 K993635 40340 Micro Detect MDI Sm/RNP Test 502 Anti-RNP-Sm Antibodies 3 HIGH January 18, 2000
2738 K980811 52093 Quest International SeraQuest Anti-Sm/RNP (manual/qualitative) 502 Anti-RNP-Sm Antibodies 3 HIGH July 10, 1998
2739 K980811 52094 Quest International SeraQuest Anti-Sm/RNP (manual/semi-quantitative) 502 Anti-RNP-Sm Antibodies 3 HIGH July 10, 1998
2741 K980811 52096 Quest International SeraQuest Anti-Sm/RNP {Hyperion HyPrep Plus} (manual calculations) 502 Anti-RNP-Sm Antibodies 3 HIGH July 10, 1998
2743 K955481 61245 TheraTest Laboratories EL-ANA Profiles (anti-RNP/Sm) 502 Anti-RNP-Sm Antibodies 3 HIGH July 19, 1996
2744 K955481 61235 TheraTest Laboratories EL-ANA/6 (ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) 502 Anti-RNP-Sm Antibodies 3 HIGH July 19, 1996
2745 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 502 Anti-RNP-Sm Antibodies 3 HIGH July 19, 1996
2746 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 502 Anti-RNP-Sm Antibodies 3 HIGH July 19, 1996
2747 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 502 Anti-RNP-Sm Antibodies 3 HIGH July 19, 1996
2748 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 502 Anti-RNP-Sm Antibodies 3 HIGH January 18, 2000
2749 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 502 Anti-RNP-Sm Antibodies 3 HIGH June 10, 1994
2750 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 502 Anti-RNP-Sm Antibodies 3 HIGH April 28, 1995
2751 K963291 16134 elias usa Varelisa ANA Profile (4) I EIA (Sm,RNP-Sm,SS-A,SS-B) 502 Anti-RNP-Sm Antibodies 3 HIGH January 10, 1997
2752 K944167 16079 elias usa Varelisa RNP-Sm Antibodies (qualitative) 502 Anti-RNP-Sm Antibodies 3 HIGH January 6, 1995
2753 K944167 16080 elias usa Varelisa RNP-Sm Antibodies (semi-quantitative) 502 Anti-RNP-Sm Antibodies 3 HIGH January 6, 1995
2754 K913360 28331 IMMCO Diagnostics Anti-Reticulin Antibody (ARA) Test 444 Anti-Reticulin Antibodies 3 HIGH October 28, 1994
2755 K981237 28528 INOVA Diagnostics QUANTA Lite Ribosome P ELISA 445 Anti-Ribosomal P Antibodies 3 HIGH July 10, 1998
2756 K950169 28441 Immuno Probe Ribosomal P EIA 445 Anti-Ribosomal P Antibodies 3 HIGH June 21, 1996
2757 K962054 4691 ALPCO ORGenTec Anti-SS-A(Ro) ELISA 446 Anti-SS-A/Ro 3 HIGH March 28, 1997
2758 K954815 4651 ALPCO ORGenTec Anti-SS-A(Ro) Pin Immuno Assay 446 Anti-SS-A/Ro 3 HIGH April 26, 1996
2759 K924951 4505 Advanced Biological Products ELISA-DOXA Combi-4 (SS-A/Ro,SS-B/LA,Sm,RNP) 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2760 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2761 K924945 4508 Advanced Biological Products ELISA-DOXA SSa Kit 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2762 K932424 4507 Apotex ANA Profile I 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2763 4316 Apotex ENA Profile ELISA 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2764 4318 Apotex SS-A ELISA 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2765 K932424 4711 Arlington Scientific ANA Profile I ELISA 446 Anti-SS-A/Ro 3 HIGH April 18, 1997
2766 4712 Arlington Scientific ENA Profile ELISA 446 Anti-SS-A/Ro 3 HIGH April 18, 1997
2767 4714 Arlington Scientific SS-A ELISA 446 Anti-SS-A/Ro 3 HIGH April 18, 1997
2769 7345 BioWhittaker RheumELISA Kit 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2770 K922241 10206 Cambridge Life Sciences AUTOZYME 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2771 K940700 10263 Cambridge Life Sciences AUTOZYME Screen 446 Anti-SS-A/Ro 3 HIGH September 15, 1994
2772 K931543 10255 Clark Laboratories ENA Combined Test Kit 446 Anti-SS-A/Ro 3 HIGH May 25, 1994
2773 K922157 10241 Clark Laboratories Encore SS-A Antigen EIA Test 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2774 K990627 10475 Cogent Diagnostics AUTOSTAT II Anti-SS-A/Ro (IgG) ELISA 446 Anti-SS-A/Ro 3 HIGH July 9, 1999
2775 13238 Diamedix Anti-SSA Microassay 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2776 K970218 13540 Diamedix Immunosimplicity (Is)-anti-SSA (manual) 446 Anti-SS-A/Ro 3 HIGH October 16, 1998
2781 22199 GenBio ImmunoWELL SS-A (Ro) Antibody Test 446 Anti-SS-A/Ro 3 HIGH August 1, 1997
2783 22050 General Biometrics ImmunoWELL SS-A (Ro) Antibody Test 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2784 K932850 25157 Helix Diagnostics Extractable Nuclear Antigen EIATest 446 Anti-SS-A/Ro 3 HIGH May 20, 1994
2785 25012 Hemagen ENA 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2786 K935828 25160 Hemagen ENA Screen 6 Kit 446 Anti-SS-A/Ro 3 HIGH September 30, 1994
2787 K946121 25187 Hemagen SS-A (Ro) ENA Kit (qualitative) 446 Anti-SS-A/Ro 3 HIGH March 3, 1995
2788 K946121 25192 Hemagen SS-A (Ro) ENA Kit (semi-quantitative) 446 Anti-SS-A/Ro 3 HIGH March 3, 1995
2790 K920383 28317 IMMCO Diagnostics Anti-ENA Antibody Test 446 Anti-SS-A/Ro 3 HIGH September 1, 1994
2791 K895339 28315 IMMCO Diagnostics Anti-SS-A(Ro) and Anti-SS-B(La) Test 446 Anti-SS-A/Ro 3 HIGH September 1, 1994
2792 K922830 28238 INOVA Diagnostics QUANTA Lite SS-A ELISA 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2793 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 446 Anti-SS-A/Ro 3 HIGH June 10, 1994
2794 28144 Immuno Concepts SS-A/SS-B Autoantibody Test System 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2795 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 446 Anti-SS-A/Ro 3 HIGH August 1, 1997
2796 K993636 40339 Micro Detect MDI SS-A Test 446 Anti-SS-A/Ro 3 HIGH January 18, 2000
2797 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 446 Anti-SS-A/Ro 3 HIGH December 22, 1999
2798 K980810 52089 Quest International SeraQuest Anti-SSA (manual/qualitative) 446 Anti-SS-A/Ro 3 HIGH July 10, 1998
2799 K980810 52090 Quest International SeraQuest Anti-SSA (manual/semi-quantitative) 446 Anti-SS-A/Ro 3 HIGH July 10, 1998
2801 K980810 52092 Quest International SeraQuest Anti-SSA {Hyperion HyPrep Plus} (manual calculations) 446 Anti-SS-A/Ro 3 HIGH July 10, 1998
2802 58021 Scimedx ENA Detect III Test System 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2803 58135 Shield Diagnostics DIASTAT ENA Profile Kit 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2805 K924262 61114 The Binding Site ENA Screening CIE 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2806 K955481 61246 TheraTest Laboratories EL-ANA Profiles (anti-SS-A) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2807 K955481 61241 TheraTest Laboratories EL-ANA Profiles (anti-SS-A, -SS-B) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2808 K955481 61235 TheraTest Laboratories EL-ANA/6 (ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2809 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2810 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2811 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 446 Anti-SS-A/Ro 3 HIGH July 19, 1996
2812 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 446 Anti-SS-A/Ro 3 HIGH January 18, 2000
2813 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 446 Anti-SS-A/Ro 3 HIGH June 10, 1994
2814 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 446 Anti-SS-A/Ro 3 HIGH October 14, 1994
2815 79022 Zeus Scientific Poly-ENA 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
2816 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 446 Anti-SS-A/Ro 3 HIGH June 10, 1994
2817 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 446 Anti-SS-A/Ro 3 HIGH October 14, 1994
2818 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 446 Anti-SS-A/Ro 3 HIGH October 14, 1994
2819 K930209 16042 elias usa Synelisa Ro-Abs/La-Abs 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
2820 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 446 Anti-SS-A/Ro 3 HIGH April 28, 1995
2821 K963291 16134 elias usa Varelisa ANA Profile (4) I EIA (Sm,RNP-Sm,SS-A,SS-B) 446 Anti-SS-A/Ro 3 HIGH January 10, 1997
2822 K944169 16091 elias usa Varelisa SS-A/Ro Antibodies (qualitative) 446 Anti-SS-A/Ro 3 HIGH January 6, 1995
2823 K944169 16092 elias usa Varelisa SS-A/Ro Antibodies (semi-quantitative) 446 Anti-SS-A/Ro 3 HIGH January 6, 1995
2824 K962052 4690 ALPCO ORGenTec Anti-SS-B(La) ELISA 447 Anti-SS-B/La 3 HIGH March 28, 1997
2825 K954832 4648 ALPCO ORGenTec Anti-SS-B(La) Pin Immuno Assay 447 Anti-SS-B/La 3 HIGH April 26, 1996
2826 K924951 4505 Advanced Biological Products ELISA-DOXA Combi-4 (SS-A/Ro,SS-B/LA,Sm,RNP) 447 Anti-SS-B/La 3 HIGH November 22, 1993
2827 K924946 4510 Advanced Biological Products ELISA-DOXA SSb Kit 447 Anti-SS-B/La 3 HIGH November 22, 1993
2828 K932424 4507 Apotex ANA Profile I 447 Anti-SS-B/La 3 HIGH November 22, 1993
2829 4316 Apotex ENA Profile ELISA 447 Anti-SS-B/La 3 HIGH July 26, 1993
2830 4319 Apotex SS-B ELISA 447 Anti-SS-B/La 3 HIGH July 26, 1993
2831 K932424 4711 Arlington Scientific ANA Profile I ELISA 447 Anti-SS-B/La 3 HIGH April 18, 1997
2832 4712 Arlington Scientific ENA Profile ELISA 447 Anti-SS-B/La 3 HIGH April 18, 1997
2833 4715 Arlington Scientific SS-B ELISA 447 Anti-SS-B/La 3 HIGH April 18, 1997
2835 7345 BioWhittaker RheumELISA Kit 447 Anti-SS-B/La 3 HIGH July 26, 1993
2836 7239 BioWhittaker RheumELISA Plus Microwell Assay 447 Anti-SS-B/La 3 HIGH July 26, 1993
2837 K922241 10206 Cambridge Life Sciences AUTOZYME 447 Anti-SS-B/La 3 HIGH November 22, 1993
2838 K922340 10243 Clark Laboratories Encore SS-B Antigen EIA Test 447 Anti-SS-B/La 3 HIGH November 22, 1993
2839 K990626 10473 Cogent Diagnostics AUTOSTAT II Anti-SS-B/La (IgG) ELISA 447 Anti-SS-B/La 3 HIGH July 9, 1999
2840 13239 Diamedix Anti-SSB Microassay 447 Anti-SS-B/La 3 HIGH July 26, 1993
2841 K970237 13539 Diamedix Immunosimplicity (Is)-anti-SSB (manual) 447 Anti-SS-B/La 3 HIGH October 16, 1998
2844 22200 GenBio ImmunoWELL SS-B (La) Antibody Test 447 Anti-SS-B/La 3 HIGH August 1, 1997
2846 22051 General Biometrics ImmunoWELL SS-B (La) Antibody Test 447 Anti-SS-B/La 3 HIGH July 26, 1993
2847 K932419 25147 Helix Diagnostics Anti-SS-B/La EIA 447 Anti-SS-B/La 3 HIGH November 22, 1993
2848 K932850 25157 Helix Diagnostics Extractable Nuclear Antigen EIATest 447 Anti-SS-B/La 3 HIGH May 20, 1994
2849 25012 Hemagen ENA 447 Anti-SS-B/La 3 HIGH July 26, 1993
2850 K935828 25160 Hemagen ENA Screen 6 Kit 447 Anti-SS-B/La 3 HIGH September 30, 1994
2851 K946120 25186 Hemagen SS-B (La) ENA Kit (qualitative) 447 Anti-SS-B/La 3 HIGH March 3, 1995
2852 K946120 25191 Hemagen SS-B (La) ENA Kit (semi-quantitative) 447 Anti-SS-B/La 3 HIGH March 3, 1995
2854 K895339 28315 IMMCO Diagnostics Anti-SS-A(Ro) and Anti-SS-B(La) Test 447 Anti-SS-B/La 3 HIGH September 1, 1994
2855 K922832 28239 INOVA Diagnostics QUANTA Lite SS-B ELISA 447 Anti-SS-B/La 3 HIGH November 22, 1993
2856 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 447 Anti-SS-B/La 3 HIGH June 10, 1994
2857 K955603 28450 Immuno Concepts RELISA SS-A/Ro - SS-B/LA 447 Anti-SS-B/La 3 HIGH August 9, 1996
2858 28144 Immuno Concepts SS-A/SS-B Autoantibody Test System 447 Anti-SS-B/La 3 HIGH July 26, 1993
2859 34046 Kallestad SSA/SSB ENA 447 Anti-SS-B/La 3 HIGH July 26, 1993
2860 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 447 Anti-SS-B/La 3 HIGH August 1, 1997
2861 K993971 40343 Micro Detect MDI SS-B Test 447 Anti-SS-B/La 3 HIGH January 18, 2000
2862 K935419 40186 Molecular Immunodiagnostics La EIA Test Kit 447 Anti-SS-B/La 3 HIGH June 10, 1994
2863 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 447 Anti-SS-B/La 3 HIGH December 22, 1999
2864 K980639 52084 Quest International SeraQuest Anti-SSB (manual/semi-quantitative) 447 Anti-SS-B/La 3 HIGH July 10, 1998
2866 K980639 52082 Quest International SeraQuest Anti-SSB {Hyperion HyPrep Plus} (manual calculations) 447 Anti-SS-B/La 3 HIGH July 10, 1998
2867 58020 Scimedx ENA Detect II Test System 447 Anti-SS-B/La 3 HIGH July 26, 1993
2868 58021 Scimedx ENA Detect III Test System 447 Anti-SS-B/La 3 HIGH July 26, 1993
2869 58135 Shield Diagnostics DIASTAT ENA Profile Kit 447 Anti-SS-B/La 3 HIGH July 26, 1993
2870 K924262 61114 The Binding Site ENA Screening CIE 447 Anti-SS-B/La 3 HIGH November 22, 1993
2871 K955481 61241 TheraTest Laboratories EL-ANA Profiles (anti-SS-A, -SS-B) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2872 K955481 61247 TheraTest Laboratories EL-ANA Profiles (anti-SS-B) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2873 61018 TheraTest Laboratories EL-ANA Profiles Test 447 Anti-SS-B/La 3 HIGH July 26, 1993
2874 K955481 61235 TheraTest Laboratories EL-ANA/6 (ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2875 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2876 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2877 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 447 Anti-SS-B/La 3 HIGH July 19, 1996
2878 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 447 Anti-SS-B/La 3 HIGH January 18, 2000
2879 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 447 Anti-SS-B/La 3 HIGH June 10, 1994
2880 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 447 Anti-SS-B/La 3 HIGH October 14, 1994
2881 79022 Zeus Scientific Poly-ENA 447 Anti-SS-B/La 3 HIGH July 26, 1993
2882 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 447 Anti-SS-B/La 3 HIGH October 14, 1994
2883 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 447 Anti-SS-B/La 3 HIGH October 14, 1994
2884 K930209 16042 elias usa Synelisa Ro-Abs/La-Abs 447 Anti-SS-B/La 3 HIGH November 22, 1993
2885 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 447 Anti-SS-B/La 3 HIGH April 28, 1995
2886 K963291 16134 elias usa Varelisa ANA Profile (4) I EIA (Sm,RNP-Sm,SS-A,SS-B) 447 Anti-SS-B/La 3 HIGH January 10, 1997
2887 K944168 16089 elias usa Varelisa SS-B(La) Antibodies (qualitative) 447 Anti-SS-B/La 3 HIGH January 6, 1995
2888 K944168 16090 elias usa Varelisa SS-B(La) Antibodies (semi-quantitative) 447 Anti-SS-B/La 3 HIGH January 6, 1995
2889 K962055 4693 ALPCO ORGenTec Anti-SCL 70 ELISA 448 Anti-Scl-70 3 HIGH March 28, 1997
2890 K954814 4652 ALPCO ORGenTec Anti-Scl 70 Pin Immuno Assay 448 Anti-Scl-70 3 HIGH April 26, 1996
2891 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 448 Anti-Scl-70 3 HIGH November 22, 1993
2892 K924949 4511 Advanced Biological Products ELISA-DOXA Scl-70 Kit 448 Anti-Scl-70 3 HIGH November 22, 1993
2893 4323 Apotex Scl-70 ELISA 448 Anti-Scl-70 3 HIGH July 26, 1993
2894 4716 Arlington Scientific Scl-70 ELISA 448 Anti-Scl-70 3 HIGH April 18, 1997
2895 K930130 7488 BioWhittaker RheumELISA II 448 Anti-Scl-70 3 HIGH November 22, 1993
2896 K922241 10206 Cambridge Life Sciences AUTOZYME 448 Anti-Scl-70 3 HIGH November 22, 1993
2897 K931543 10255 Clark Laboratories ENA Combined Test Kit 448 Anti-Scl-70 3 HIGH May 25, 1994
2898 K990797 10470 Cogent Diagnostics AUTOSTAT II Anti-Scl-70 (IgG) ELISA 448 Anti-Scl-70 3 HIGH July 9, 1999
2899 13240 Diamedix Anti-Scl-70 Microassay 448 Anti-Scl-70 3 HIGH July 26, 1993
2900 K970239 13536 Diamedix Immunosimplicity (Is)-anti-Scl-70 (manual) 448 Anti-Scl-70 3 HIGH October 16, 1998
2901 K951798 25232 Helix Diagnostics Anti-Scl-70 EIA 448 Anti-Scl-70 3 HIGH July 28, 1995
2902 25012 Hemagen ENA 448 Anti-Scl-70 3 HIGH July 26, 1993
2903 K935828 25160 Hemagen ENA Screen 6 Kit 448 Anti-Scl-70 3 HIGH September 30, 1994
2904 K946122 25188 Hemagen Scl-70 ENA Kit (qualitative) 448 Anti-Scl-70 3 HIGH March 3, 1995
2905 K946122 25193 Hemagen Scl-70 ENA Kit (semi-quantitative) 448 Anti-Scl-70 3 HIGH March 3, 1995
2907 K903314 28316 IMMCO Diagnostics Anti-Scl-70 Antibody Test 448 Anti-Scl-70 3 HIGH September 1, 1994
2908 K924898 28274 INOVA Diagnostics QUANTA Lite Scl-70 ELISA 448 Anti-Scl-70 3 HIGH November 22, 1993
2909 K955602 28452 Immuno Concepts RELISA Scl-70 448 Anti-Scl-70 3 HIGH August 9, 1996
2910 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 448 Anti-Scl-70 3 HIGH August 1, 1997
2911 K935418 40181 Molecular Immunodiagnostics Scl-70 EIA Test Kit 448 Anti-Scl-70 3 HIGH June 10, 1994
2912 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 448 Anti-Scl-70 3 HIGH December 22, 1999
2914 K924262 61114 The Binding Site ENA Screening CIE 448 Anti-Scl-70 3 HIGH November 22, 1993
2915 K955481 61248 TheraTest Laboratories EL-ANA Profiles (anti-Scl-70) 448 Anti-Scl-70 3 HIGH July 19, 1996
2916 K950716 61018 TheraTest Laboratories EL-ANA Profiles Test 448 Anti-Scl-70 3 HIGH October 6, 1995
2917 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 448 Anti-Scl-70 3 HIGH July 19, 1996
2918 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 448 Anti-Scl-70 3 HIGH July 19, 1996
2919 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 448 Anti-Scl-70 3 HIGH January 18, 2000
2920 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 448 Anti-Scl-70 3 HIGH June 10, 1994
2921 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 448 Anti-Scl-70 3 HIGH October 14, 1994
2922 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 448 Anti-Scl-70 3 HIGH June 10, 1994
2923 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 448 Anti-Scl-70 3 HIGH October 14, 1994
2924 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 448 Anti-Scl-70 3 HIGH October 14, 1994
2925 K930417 16039 elias usa Synelisa Scl-70 Antibodies EIA Kit 448 Anti-Scl-70 3 HIGH November 22, 1993
2926 K944172 16083 elias usa Varelisa Scl-70 Antibodies (qualitative) 448 Anti-Scl-70 3 HIGH January 6, 1995
2927 K944172 16084 elias usa Varelisa Scl-70 Antibodies (semi-quantitative) 448 Anti-Scl-70 3 HIGH January 6, 1995
2928 K955021 28440 INOVA Diagnostics QUANTA Lite PR3 ELISA 522 Anti-Serine Protease 3 (PR3) Antibodies 3 HIGH April 19, 1996
2929 K981328 28529 INOVA Diagnostics QUANTA Lite PR3 IgG ELISA 522 Anti-Serine Protease 3 (PR3) Antibodies 3 HIGH August 14, 1998
2930 28313 IMMCO Diagnostics Anti-Skin Antibody Test 449 Anti-Skin (Epidermal) Antibodies 3 HIGH September 1, 1994
2931 40028 MeDiCa ASA Test Kit 449 Anti-Skin (Epidermal) Antibodies 3 HIGH July 26, 1993
2932 58013 Scimedx ASA Test System 449 Anti-Skin (Epidermal) Antibodies 3 HIGH July 26, 1993
2933 K981209 61358 The Binding Site Monkey Oesophagus IFA 449 Anti-Skin (Epidermal) Antibodies 3 HIGH October 30, 1998
2934 79003 Zeus Scientific Anti-Skin Antibody 449 Anti-Skin (Epidermal) Antibodies 3 HIGH July 26, 1993
2935 K962062 4692 ALPCO ORGenTec Anti-Sm(Smith) ELISA 450 Anti-Sm (Smith) 3 HIGH March 28, 1997
2936 K954830 4646 ALPCO ORGenTec Anti-Sm(Smith) Pin Immuno Assay 450 Anti-Sm (Smith) 3 HIGH May 17, 1996
2937 K924951 4505 Advanced Biological Products ELISA-DOXA Combi-4 (SS-A/Ro,SS-B/LA,Sm,RNP) 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2938 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2939 K924947 4509 Advanced Biological Products ELISA-DOXA Sm Kit 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2940 K924948 4506 Advanced Biological Products ELISA-DOXA Sm/RNP Kit 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2941 K932424 4507 Apotex ANA Profile I 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2942 4316 Apotex ENA Profile ELISA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2943 4320 Apotex SM ELISA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2944 4310 Apotex SM/RNP ELISA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2945 K932424 4711 Arlington Scientific ANA Profile I ELISA 450 Anti-Sm (Smith) 3 HIGH April 18, 1997
2946 4712 Arlington Scientific ENA Profile ELISA 450 Anti-Sm (Smith) 3 HIGH April 18, 1997
2947 4717 Arlington Scientific Sm ELISA 450 Anti-Sm (Smith) 3 HIGH April 18, 1997
2948 4713 Arlington Scientific Sm/RNP ELISA 450 Anti-Sm (Smith) 3 HIGH April 18, 1997
2950 7145 BioHyTech EIA Kit 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2952 7345 BioWhittaker RheumELISA Kit 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2953 K922241 10206 Cambridge Life Sciences AUTOZYME 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2954 K940700 10263 Cambridge Life Sciences AUTOZYME Screen 450 Anti-Sm (Smith) 3 HIGH September 15, 1994
2955 K931543 10255 Clark Laboratories ENA Combined Test Kit 450 Anti-Sm (Smith) 3 HIGH May 25, 1994
2956 K921572 10244 Clark Laboratories Encore Sm Antigen EIA Test 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2957 K921870 10240 Clark Laboratories Encore Sm/RNP Antigen EIA Test 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2958 K990624 10471 Cogent Diagnostics AUTOSTAT II Anti-Sm/RNP (IgG) ELISA 450 Anti-Sm (Smith) 3 HIGH July 9, 1999
2959 13241 Diamedix Anti-Sm Microassay 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2960 K970220 13538 Diamedix Immunosimplicity (Is)-anti-Sm (manual) 450 Anti-Sm (Smith) 3 HIGH October 16, 1998
2963 22206 GenBio ImmunoWELL RNP/Sm Ab Test 450 Anti-Sm (Smith) 3 HIGH August 1, 1997
2964 22201 GenBio ImmunoWELL Sm Antibody Test 450 Anti-Sm (Smith) 3 HIGH August 1, 1997
2966 22117 General Biometrics ImmunoWELL RNP/Sm Ab Test 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2967 22052 General Biometrics ImmunoWELL Sm Antibody Test 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2968 K940510 25162 Helix Diagnostics Anti-Sm Ab EIA Test 450 Anti-Sm (Smith) 3 HIGH September 15, 1994
2969 K932850 25157 Helix Diagnostics Extractable Nuclear Antigen EIATest 450 Anti-Sm (Smith) 3 HIGH May 20, 1994
2970 25012 Hemagen ENA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2971 K935828 25160 Hemagen ENA Screen 6 Kit 450 Anti-Sm (Smith) 3 HIGH September 30, 1994
2972 K946123 25196 Hemagen Sm ENA Kit (qualitative) 450 Anti-Sm (Smith) 3 HIGH March 10, 1995
2973 K946123 25197 Hemagen Sm ENA Kit (semi-quantitative) 450 Anti-Sm (Smith) 3 HIGH March 10, 1995
2975 K920385 28317 IMMCO Diagnostics Anti-ENA Antibody Test 450 Anti-Sm (Smith) 3 HIGH September 1, 1994
2976 K895338 28314 IMMCO Diagnostics Anti-RNP and Anti-Sm Antibody Test 450 Anti-Sm (Smith) 3 HIGH September 1, 1994
2977 K922831 28237 INOVA Diagnostics QUANTA Lite SM ELISA 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2978 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 450 Anti-Sm (Smith) 3 HIGH June 10, 1994
2979 K955604 28451 Immuno Concepts RELISA Sm/RNP 450 Anti-Sm (Smith) 3 HIGH August 9, 1996
2980 34047 Kallestad Sm/RNP ENA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2981 K964787 40267 MarDx ENA IgG MARSTRIPE Immunostripe System 450 Anti-Sm (Smith) 3 HIGH August 1, 1997
2982 K994029 40341 Micro Detect MDI Sm Test 450 Anti-Sm (Smith) 3 HIGH January 18, 2000
2983 K935414 40185 Molecular Immunodiagnostics SM EIA Test Kit 450 Anti-Sm (Smith) 3 HIGH June 10, 1994
2984 K993109 49229 Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/Ro,SS-B/La,Scl-70,Centromere,Jo-1) 450 Anti-Sm (Smith) 3 HIGH December 22, 1999
2985 K980540 52085 Quest International SeraQuest Anti-Sm (manual/qualitative) 450 Anti-Sm (Smith) 3 HIGH July 10, 1998
2986 K980540 52086 Quest International SeraQuest Anti-Sm (manual/semi-quantitative) 450 Anti-Sm (Smith) 3 HIGH July 10, 1998
2988 K980540 52088 Quest International SeraQuest Anti-Sm {Hyperion HyPrep Plus} (manual calculations) 450 Anti-Sm (Smith) 3 HIGH July 10, 1998
2989 55011 Reaads Medical Products Anti-ENA (Sm/RNP complex) Qualitative Test 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2990 55012 Reaads Medical Products Anti-Sm Qualitative Test 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2991 58019 Scimedx ENA Detect I Test System 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2992 58021 Scimedx ENA Detect III Test System 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2993 58135 Shield Diagnostics DIASTAT ENA Profile Kit 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2995 K924262 61114 The Binding Site ENA Screening CIE 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
2996 K955481 61244 TheraTest Laboratories EL-ANA Profiles (anti-Sm) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
2997 K955481 61240 TheraTest Laboratories EL-ANA Profiles (anti-Sm, -RNP) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
2998 61018 TheraTest Laboratories EL-ANA Profiles Test 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
2999 K955481 61235 TheraTest Laboratories EL-ANA/6 (ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
3000 K955481 61236 TheraTest Laboratories EL-ANA/7H (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
3001 K955481 61237 TheraTest Laboratories EL-ANA/7S (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
3002 K955481 61238 TheraTest Laboratories EL-ANA/8 (ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) 450 Anti-Sm (Smith) 3 HIGH July 19, 1996
3003 K993839 61462 Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/La,Scl-70,Jo-1) 450 Anti-Sm (Smith) 3 HIGH January 18, 2000
3004 K933267 79042 Zeus Scientific Autoantibody Profile-6 ELISA 450 Anti-Sm (Smith) 3 HIGH June 10, 1994
3005 K941409 79045 Zeus Scientific ENA Profile-6 ELISA 450 Anti-Sm (Smith) 3 HIGH October 14, 1994
3006 79022 Zeus Scientific Poly-ENA 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
3007 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 450 Anti-Sm (Smith) 3 HIGH June 10, 1994
3008 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 450 Anti-Sm (Smith) 3 HIGH October 14, 1994
3009 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 450 Anti-Sm (Smith) 3 HIGH October 14, 1994
3010 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 450 Anti-Sm (Smith) 3 HIGH April 28, 1995
3011 K963291 16134 elias usa Varelisa ANA Profile (4) I EIA (Sm,RNP-Sm,SS-A,SS-B) 450 Anti-Sm (Smith) 3 HIGH January 10, 1997
3012 K944170 16087 elias usa Varelisa Sm Antibodies (qualitative) 450 Anti-Sm (Smith) 3 HIGH January 6, 1995
3013 K944170 16088 elias usa Varelisa Sm Antibodies (semi-quantitative) 450 Anti-Sm (Smith) 3 HIGH January 6, 1995
3014 7112 Behring AFT System I 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3015 28311 IMMCO Diagnostics Autoantibody Test System 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH September 1, 1994
3016 28042 Incstar Fluoro-Kit 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3017 40008 MarDx Autoimmune IFA Screening Test System 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3018 40018 MarDx Smooth Muscle Antibody Test System 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3019 40029 MeDiCa ASMA Test Kit 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3020 40031 MeDiCa Multiple Antibody Test Kit 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3021 58011 Sanofi/Kallestad Quantifluor Kit 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3022 58028 Scimedx SMA Test System 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3023 K955431 61254 The Binding Site Rat Liver, Kidney, Stomach IFA 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH September 6, 1996
3024 79032 Zeus Scientific Autoantibody Screen (AAS) 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3025 79024 Zeus Scientific SMA 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH July 26, 1993
3082 K952130 4621 ALPCO ORGenTec Anti-TG ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH June 23, 1995
3083 K950089 4618 ALPCO ORGenTec Anti-TG Pin Immuno Assay 453 Anti-Thyroglobulin Antibodies 3 HIGH May 5, 1995
3084 K950088 4617 ALPCO ORGenTec Anti-TG/TPO Pin Immuno Assay Combikit 453 Anti-Thyroglobulin Antibodies 3 HIGH May 5, 1995
3085 K971835 4842 Alfa Scientific Designs Anti-Thyroglobulin (Anti-Tg) Microplate ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH July 23, 1999
3087 4153 Ames Sera-tek 453 Anti-Thyroglobulin Antibodies 3 HIGH July 26, 1993
3088 K992790 8243 BRAHMS Diagnostica DYNOtest Anti-Tg 453 Anti-Thyroglobulin Antibodies 3 HIGH December 10, 1999
3089 K936010 7531 Biomerica Anti-Thyroglobulin ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH September 30, 1994
3092 K925826 10239 Clark Laboratories Encore Thyroglobulin EIA Test 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3093 K923370 10207 Cogent Diagnostics AUTOSTAT Autoantibody Test Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3094 K943625 10267 Cogent Diagnostics AUTOSTAT II Autoantibody Test Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH January 6, 1995
3095 K983553 13591 Diamedix Immunosimplicity (Is)-anti-TG IgG (manual/qualitative) 453 Anti-Thyroglobulin Antibodies 3 HIGH November 19, 1999
3096 K983553 13592 Diamedix Immunosimplicity (Is)-anti-TG IgG (manual/quantitative) 453 Anti-Thyroglobulin Antibodies 3 HIGH November 19, 1999
3098 K953066 19024 Fujirebio Serodia-ATG 453 Anti-Thyroglobulin Antibodies 3 HIGH November 3, 1995
3100 22211 GenBio ImmunoWELL Thyroglobulin Ab Test 453 Anti-Thyroglobulin Antibodies 3 HIGH August 1, 1997
3102 22122 General Biometrics ImmunoWELL Thyroglobulin Ab Test 453 Anti-Thyroglobulin Antibodies 3 HIGH July 26, 1993
3104 K962341 25269 Hycor HY-TEC Thyroglobulin (TG) Antibodies (manual) 453 Anti-Thyroglobulin Antibodies 3 HIGH June 13, 1997
3105 K960370 28443 IMMCO Diagnostics ImmuLisa Anti-Thyroglobulin (Tg) Ab ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH July 5, 1996
3106 K930486 28271 INOVA Diagnostics QUANTA Lite Thyroid T ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3107 K941358 28348 Immuno Probe Thyroglobulin EIA 453 Anti-Thyroglobulin Antibodies 3 HIGH October 14, 1994
3108 K925194 31010 Joldon Diagnostics Thyroglobulin Auto-Antibody EIA Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3109 34023 Kronus Kalibre-R Thyroglobulin Antibody RIA Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH July 26, 1993
3110 K951362 40235 MarDx Thyroglobulin EIA Test Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH December 8, 1995
3111 K971835 40287 Monobind Anti-Thyroglobulin (Anti-Tg) Microplate ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH February 20, 1998
3112 40158 Murex Thymune-T 453 Anti-Thyroglobulin Antibodies 3 HIGH July 26, 1993
3114 K930777 43075 Nichols Institute Chemiluminescence Anti-TG Assay 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3118 K952183 58373 Shield Diagnostics DIASTAT Anti-Tg Kit (qualitative) 453 Anti-Thyroglobulin Antibodies 3 HIGH July 28, 1995
3119 K952183 58372 Shield Diagnostics DIASTAT Anti-Tg Kit (quantitative) 453 Anti-Thyroglobulin Antibodies 3 HIGH July 28, 1995
3123 K984165 61387 The Binding Site BINDAZYME Anti-Thyroglobulin EIA 453 Anti-Thyroglobulin Antibodies 3 HIGH May 7, 1999
3124 70138 Wellcome Thymune-T 453 Anti-Thyroglobulin Antibodies 3 HIGH July 26, 1993
3125 K991179 79067 Zeus Scientific Thyroglobulin IgG ELISA 453 Anti-Thyroglobulin Antibodies 3 HIGH August 27, 1999
3126 K933123 16032 elias usa Synelisa TG Abs/TPO Abs EIA Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3127 K925922 16034 elias usa elias TGAb EIA Kit 453 Anti-Thyroglobulin Antibodies 3 HIGH November 22, 1993
3128 28046 Incstar MT Fluoro-Kit 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3129 40006 MarDx Anti-Thyroid Antibody Test System 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3130 40030 MeDiCa ATA Test Kit 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3131 58011 Sanofi/Kallestad Quantifluor Kit 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3132 58029 Scimedx TA Test System 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3133 79025 Zeus Scientific TA 454 Anti-Thyroid Antibodies 3 HIGH July 26, 1993
3134 4153 Ames Sera-tek 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3135 K943580 10267 Cogent Diagnostics AUTOSTAT II Autoantibody Test Kit 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH April 28, 1995
3137 22198 GenBio ImmunoWELL Microsomal(Recomb.TPO)Ab Test 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH August 1, 1997
3138 22212 GenBio ImmunoWELL Microsome (TPO) Ab Test 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH August 1, 1997
3140 22049 General Biometrics ImmunoWELL Microsomal(Recomb.TPO)Ab Test 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3141 22123 General Biometrics ImmunoWELL Microsome (TPO) Ab Test 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3142 K930485 28272 INOVA Diagnostics QUANTA Lite Thyroid M ELISA 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH November 22, 1993
3143 K941361 28349 Immuno Probe Microsomal EIA 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH October 14, 1994
3144 K930274 31009 Joldon Diagnostics TMA Auto-Antibody EIA Kit 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH November 22, 1993
3145 34021 Kronus Kalibre TPO Antibody RIA Kit 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3146 K951364 40242 MarDx Microsomal EIA 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH December 15, 1995
3147 40157 Murex Thymune-M 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3148 K926553 49109 Polymedco LUMItest anti-TPO (computer calculations) 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH September 30, 1994
3149 K926553 49110 Polymedco LUMItest anti-TPO (manual calculations) 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH September 30, 1994
3150 70137 Wellcome Thymune-M 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH July 26, 1993
3151 K925923 16035 elias usa elias TMAb EIA Kit 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH November 22, 1993
3152 K950088 4617 ALPCO ORGenTec Anti-TG/TPO Pin Immuno Assay Combikit 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH May 5, 1995
3153 K952129 4622 ALPCO ORGenTec Anti-TPO ELISA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH June 23, 1995
3154 K950090 4619 ALPCO ORGenTec Anti-TPO Pin Immuno Assay 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH May 5, 1995
3155 K971834 4840 Alfa Scientific Designs Anti-Thyroid Peroxidase (Anti-TPO) Microplate ELISA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH July 23, 1999
3157 K992791 8242 BRAHMS Diagnostica DYNOtest Anti-TPO 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH December 10, 1999
3161 K960369 28442 IMMCO Diagnostics ImmuLisa Anti-Thyroid Peroxidase (TPO) Ab 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH July 5, 1996
3162 K981857 28531 INOVA Diagnostics QUANTA Lite TPO ELISA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH September 4, 1998
3163 K971834 40290 Monobind Anti-Thyroid Peroxidase (Anti-TPO) Microplate ELISA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH February 20, 1998
3165 K931311 43076 Nichols Institute Chemiluminescence Anti-TPO Assay 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH November 22, 1993
3168 K993585 49225 Pharmacia & Upjohn Varelisa TPO Antibodies EIA (qualitative) 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH January 7, 2000
3169 K993585 49226 Pharmacia & Upjohn Varelisa TPO Antibodies EIA (quantitative) 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH January 7, 2000
3170 K951487 58377 Shield Diagnostics DIASTAT Anti-TPO Kit (qualitative) 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH September 8, 1995
3171 K951487 58378 Shield Diagnostics DIASTAT Anti-TPO Kit (semi-quantitative) 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH September 8, 1995
3175 K984163 61388 The Binding Site BINDAZYME Anti-TPO EIA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH February 12, 1999
3176 K933123 16032 elias usa Synelisa TG Abs/TPO Abs EIA Kit 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH November 22, 1993
3177 K992878 28569 IMMCO Diagnostics ImmuLisa Anti-Tissue Transglutaminase (tTG) Ab ELISA (qualitative) 546 Anti-Tissue Transglutaminase (tTG) 3 HIGH January 7, 2000
3178 K992878 28570 IMMCO Diagnostics ImmuLisa Anti-Tissue Transglutaminase (tTG) Ab ELISA (semi-quantitative) 546 Anti-Tissue Transglutaminase (tTG) 3 HIGH January 7, 2000
3179 K982366 28533 INOVA Diagnostics QUANTA Lite tTG (tissue transglutaminase) ELISA 546 Anti-Tissue Transglutaminase (tTG) 3 HIGH October 16, 1998
3180 K993612 61463 The Binding Site BINDAZYME Anti-Transglutaminase IgA EIA 546 Anti-Tissue Transglutaminase (tTG) 3 HIGH January 27, 2000
3181 K933716 4334 Abbott COMMANDER System 503 Anti-Trypanosoma cruzi Antibodies 3 HIGH December 23, 1994
3182 K933716 4535 Abbott Chagas Antibody EIA (IgG) 503 Anti-Trypanosoma cruzi Antibodies 3 HIGH December 23, 1994
3183 K911233 22173 Gull Laboratories Chagas IgG ELISA 503 Anti-Trypanosoma cruzi Antibodies 3 HIGH November 10, 1994
3184 K930272 25159 Hemagen Chagas' Kit 503 Anti-Trypanosoma cruzi Antibodies 3 HIGH May 26, 1995
3185 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 501 Anti-U1-snRNP Antibodies 3 HIGH June 10, 1994
3186 K940229 16064 elias usa Synelisa ENA Screen (qualitative) 501 Anti-U1-snRNP Antibodies 3 HIGH October 14, 1994
3187 K940229 16065 elias usa Synelisa ENA Screen (semi-quantitative) 501 Anti-U1-snRNP Antibodies 3 HIGH October 14, 1994
3188 K930142 16033 elias usa Synelisa U1-snRNP Antibodies EIA Kit 501 Anti-U1-snRNP Antibodies 3 HIGH September 1, 1994
3189 K951205 16110 elias usa Varelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 501 Anti-U1-snRNP Antibodies 3 HIGH April 28, 1995
3190 4428 American Bioproducts STACHROM Antiplasmin Test Kit 483 Antiplasmin 4 HIGH July 26, 1993
3191 46128 Ortho Koagulab CTS 483 Antiplasmin 4 HIGH July 26, 1993
3192 K942117 4594 American Bioproducts STA Analyzer 456 Antithrombin III (ATIII) 4 HIGH February 17, 1995
3193 K983460 4875 American Bioproducts STA-R Analyzer 456 Antithrombin III (ATIII) 4 HIGH October 25, 1999
3194 4358 American Diagnostica Actichrome Antithrombin III 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3195 K936196 7535 Baxter Antithrombin III Chromogenic Assay 456 Antithrombin III (ATIII) 4 HIGH September 30, 1994
3198 7383 Beckman Auto ICS 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3199 7381 Beckman ICS 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3200 7382 Beckman ICS II 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3202 K955278 7824 Behring Coagulation Timer (BCT) 456 Antithrombin III (ATIII) 4 HIGH November 15, 1996
3206 7119 Behring Nor-partigen Kit 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3207 7193 Bio/Data PAP-4C 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3208 K960871 7929 Biopool Spectrolyse Antithrombin III (anti-Xa) 456 Antithrombin III (ATIII) 4 HIGH August 15, 1997
3213 K952515 10314 Chromogenix COACUTE Antithrombin R (manual) 456 Antithrombin III (ATIII) 4 HIGH January 27, 2000
3214 K936196 13488 Dade Antithrombin III Chromogenic Assay 456 Antithrombin III (ATIII) 4 HIGH April 17, 1998
3216 K981711 13548 Dade Behring Sysmex CA-500 Series 456 Antithrombin III (ATIII) 4 HIGH April 2, 1999
3219 K935307 13292 Dade Thrombin-Antithrombin (TAT) Complex ELISA 456 Antithrombin III (ATIII) 4 HIGH January 20, 1995
3221 13152 Diagnostica Stago LIATEST AT III 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3227 K951943 25242 Helena Laboratories Chrom Z-AT (manual) 456 Antithrombin III (ATIII) 4 HIGH November 24, 1995
3228 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3229 K951943 25029 Helena Laboratories PACKS-4 456 Antithrombin III (ATIII) 4 HIGH November 24, 1995
3230 25005 Helena Laboratories Quiplate System for RID 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3231 K980499 28073 Instrumentation Laboratory IL ACL 100 456 Antithrombin III (ATIII) 4 HIGH December 8, 1998
3232 K980499 28074 Instrumentation Laboratory IL ACL 1000 456 Antithrombin III (ATIII) 4 HIGH December 8, 1998
3233 28075 Instrumentation Laboratory IL ACL 200 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3234 28076 Instrumentation Laboratory IL ACL 2000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3235 28197 Instrumentation Laboratory IL ACL 300 Plus 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3236 28078 Instrumentation Laboratory IL ACL 3000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3237 28079 Instrumentation Laboratory IL ACL 3000 Plus 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3238 K961991 28454 Instrumentation Laboratory IL ACL 6000 456 Antithrombin III (ATIII) 4 HIGH September 13, 1996
3239 K961991 28487 Instrumentation Laboratory IL ACL 7000 456 Antithrombin III (ATIII) 4 HIGH September 19, 1997
3240 28080 Instrumentation Laboratory IL ACL 810 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3241 K951891 28395 Instrumentation Laboratory IL ACL Futura System 456 Antithrombin III (ATIII) 4 HIGH November 9, 1995
3242 28183 Instrumentation Laboratory Multistat III 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3243 28184 Instrumentation Laboratory Multistat III Plus 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3244 K931420 34061 Kabi Pharmacia COATEST Antithrombin (manual) 456 Antithrombin III (ATIII) 4 HIGH October 14, 1994
3245 34010 Kent Radial Immunodiffusion Test 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3246 37034 LAbor COA Data 2000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3247 37033 LAbor COA Screener 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3248 37035 LAbor COA System 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3249 K972144 40302 Medical Laboratory MLA Electra 1000C {Sigma Diagnostics ACCUCOLOR Antithrombin III} 456 Antithrombin III (ATIII) 4 HIGH June 19, 1998
3250 K944227 40208 Medical Laboratory MLA Electra 1400C 456 Antithrombin III (ATIII) 4 HIGH April 7, 1995
3251 K931206 40167 Medical Laboratory MLA Electra 1600C 456 Antithrombin III (ATIII) 4 HIGH November 22, 1993
3252 K962664 40282 Medical Laboratory MLA Electra 1800C 456 Antithrombin III (ATIII) 4 HIGH December 5, 1997
3253 40042 Medical Laboratory MLA Electra 900C 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3254 K972144 40301 Medical Laboratory MLA Electra 900C {Sigma Diagnostics ACCUCOLOR Antithrombin III} 456 Antithrombin III (ATIII) 4 HIGH June 19, 1998
3255 46093 Organon Teknika Chromostrate Antithrombin III Assay 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3256 K962857 46269 Organon Teknika Coag-A-Mate MTX 456 Antithrombin III (ATIII) 4 HIGH January 23, 1998
3257 K924453 46144 Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 456 Antithrombin III (ATIII) 4 HIGH November 22, 1993
3258 46128 Ortho Koagulab CTS 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3259 K992130 49231 Pacific Hemostasis ThromboScreen 400C 456 Antithrombin III (ATIII) 4 HIGH January 28, 2000
3268 K935308 58320 Sigma Diagnostics ACCUCOLOR Antithrombin III 456 Antithrombin III (ATIII) 4 HIGH September 30, 1994
3269 58049 Sigma Diagnostics AccuStasis 1000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3270 58050 Sigma Diagnostics AccuStasis 2000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3271 K955720 58413 Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) 456 Antithrombin III (ATIII) 4 HIGH September 27, 1996
3272 K955720 58414 Sigma Diagnostics Amelung AMAX CS-190 (manual dilution) 456 Antithrombin III (ATIII) 4 HIGH September 27, 1996
3273 K972260 58517 Sigma Diagnostics Amelung CS-400 (auto dilution) 456 Antithrombin III (ATIII) 4 HIGH June 19, 1998
3274 K972260 58516 Sigma Diagnostics Amelung CS-400 (manual dilution) 456 Antithrombin III (ATIII) 4 HIGH June 19, 1998
3275 K964139 58606 Sysmex CA-6000 456 Antithrombin III (ATIII) 4 HIGH January 27, 2000
3276 K964139 61283 TOA Medical Electronics CA-6000 456 Antithrombin III (ATIII) 4 HIGH April 11, 1997
3277 61068 The Binding Site Human Antithrombin III RID 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
3278 K931992 67075 Vitek HEMOLAB 456 Antithrombin III (ATIII) 4 HIGH January 6, 1995
3280 4035 Abbott Bichromatic ABA 100 462 Apolipoprotein A1 2 HIGH July 26, 1993
3281 4036 Abbott Bichromatic ABA 200 462 Apolipoprotein A1 2 HIGH July 26, 1993
3316 16010 Electronucleonics FLEXIGEM 462 Apolipoprotein A1 2 HIGH July 26, 1993
3320 K893885 25221 Horizon Apolipoprotein A-1 (APO A-1) (manual) 462 Apolipoprotein A1 2 HIGH April 28, 1995
3327 28183 Instrumentation Laboratory Multistat III 462 Apolipoprotein A1 2 HIGH July 26, 1993
3328 28191 Isolab Immunoturbidimetric Assay 462 Apolipoprotein A1 2 HIGH July 26, 1993
3329 40124 Medical Analysis Systems RefLab Test Kit 462 Apolipoprotein A1 2 HIGH July 26, 1993
3330 K931777 43077 Nichols Institute Chemiluminescence APO-A1 Assay 462 Apolipoprotein A1 2 HIGH November 22, 1993
3346 K950383 55106 Randox Laboratories Test Kit 462 Apolipoprotein A1 2 HIGH January 26, 1996
3347 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 462 Apolipoprotein A1 2 HIGH July 26, 1993
3374 58051 Sigma Diagnostics Test Kit 462 Apolipoprotein A1 2 HIGH July 26, 1993
3384 4035 Abbott Bichromatic ABA 100 457 Apolipoprotein B 2 HIGH July 26, 1993
3385 4036 Abbott Bichromatic ABA 200 457 Apolipoprotein B 2 HIGH July 26, 1993
3402 7118 Behring M-partigen Kit 457 Apolipoprotein B 2 HIGH July 26, 1993
3423 16010 Electronucleonics FLEXIGEM 457 Apolipoprotein B 2 HIGH July 26, 1993
3432 28183 Instrumentation Laboratory Multistat III 457 Apolipoprotein B 2 HIGH July 26, 1993
3433 28184 Instrumentation Laboratory Multistat III Plus 457 Apolipoprotein B 2 HIGH July 26, 1993
3435 28191 Isolab Immunoturbidimetric Assay 457 Apolipoprotein B 2 HIGH July 26, 1993
3436 40124 Medical Analysis Systems RefLab Test Kit 457 Apolipoprotein B 2 HIGH July 26, 1993
3437 K925702 43073 Nichols Institute Chemiluminescence APO-B Assay 457 Apolipoprotein B 2 HIGH November 22, 1993
3454 K950382 55106 Randox Laboratories Test Kit 457 Apolipoprotein B 2 HIGH January 26, 1996
3455 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 457 Apolipoprotein B 2 HIGH July 26, 1993
3481 58051 Sigma Diagnostics Test Kit 457 Apolipoprotein B 2 HIGH July 26, 1993
3489 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 515 Arginine 2 HIGH November 10, 1994
3490 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 515 Arginine 2 HIGH May 26, 1995
3491 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 509 Asparagine 2 HIGH November 10, 1994
3492 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 509 Asparagine 2 HIGH May 26, 1995
3497 4035 Abbott Bichromatic ABA 100 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3498 4036 Abbott Bichromatic ABA 200 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3499 4267 Abbott Bichromatic ABA 50 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3510 4143 American Monitor KDA 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3511 4144 American Monitor Parallel 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3558 13216 DMA Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3569 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3582 16010 Electronucleonics FLEXIGEM 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3588 K951751 25234 HiChem Aspartate Transaminase (AST) (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH August 18, 1995
3589 K880276 25215 Horizon AST (SGOT) (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH April 28, 1995
3597 28183 Instrumentation Laboratory Multistat III 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3598 28184 Instrumentation Laboratory Multistat III Plus 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3627 40126 Mallinckrodt Serometer 370 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3628 K952743 40241 MeDiTech Aspartate Aminotranspherase (AST) (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH December 15, 1995
3629 40124 Medical Analysis Systems RefLab Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3654 49064 Pointe Scientific 180 Chemistry Analyzer 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3656 55075 Reagents Applications RAICHEM Test Kit (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3684 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3685 58185 Seragen StatEase 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3686 58051 Sigma Diagnostics Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3687 58195 SmithKline ESKALAB-CCS 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3688 58210 Stanbio Premiere 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3689 58157 Stanbio Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3690 58229 Sterling Diagnostics Analyzer 2000 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3691 58230 Sterling Diagnostics Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3694 K875071 61400 TECO Diagnostics AST (SGOT) Reagent Set (manual) 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH March 26, 1999
3695 K882938 61377 TECO Diagnostics TC 84 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH November 19, 1998
3696 61044 TRACE Scientific Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3708 61014 Technicon SMA 12/60 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3709 61016 Technicon SMAC 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3710 61045 Technicon SMAC 2 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3711 61046 Technicon SMAC 3 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
3715 28124 Immuno-Mycologics Aspergillus Antigens and Control Sera 465 Aspergillus Antibodies 3 HIGH July 26, 1993
3725 4275 Ames OPTIMATE 701 Barbiturates 7 HIGH July 26, 1993
3729 K945344 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3733 K945344 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3738 K945344 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3743 K945344 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH April 10, 1998
3751 K945344 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3755 K945344 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3762 K945344 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
3776 13030 Diagnostic Products Corp. Coat-A-Count 701 Barbiturates 7 HIGH July 26, 1993
3788 19013 Finnigan MAT Witness System 701 Barbiturates 7 HIGH July 26, 1993
3793 28183 Instrumentation Laboratory Multistat III 701 Barbiturates 7 HIGH July 26, 1993
3794 28184 Instrumentation Laboratory Multistat III Plus 701 Barbiturates 7 HIGH July 26, 1993
3820 55098 Roche Diagnostics Abuscreen RIA 701 Barbiturates 7 HIGH July 26, 1993
3833 K945344 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH May 7, 1999
3835 K945344 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH May 7, 1999
3841 K945344 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH May 7, 1999
3844 K945344 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH May 7, 1999
3855 58188 Syva Emit st Drug Detection System 701 Barbiturates 7 HIGH July 26, 1993
3856 58190 Syva Qstat/Qst System 701 Barbiturates 7 HIGH July 26, 1993
3872 4275 Ames OPTIMATE 702 Benzodiazepines 7 HIGH July 26, 1993
3876 K951710 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3881 K951710 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3886 K951710 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3890 K951710 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH April 10, 1998
3891 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 702 Benzodiazepines 7 HIGH August 23, 1996
3892 7279 Bio-Rad HPLC 702 Benzodiazepines 7 HIGH July 26, 1993
3893 K955116 7744 Bio-Rad REMEDi HS-Urine Benzodiazepine Assay 702 Benzodiazepines 7 HIGH February 9, 1996
3907 K951710 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3910 K951710 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3924 13109 Diagnostic Products Corp. Coat-A-Count IRMA 702 Benzodiazepines 7 HIGH July 26, 1993
3938 28184 Instrumentation Laboratory Multistat III Plus 702 Benzodiazepines 7 HIGH July 26, 1993
3944 K951710 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
3965 55098 Roche Diagnostics Abuscreen RIA 702 Benzodiazepines 7 HIGH July 26, 1993
3977 K951710 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH May 7, 1999
3980 K951710 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH May 7, 1999
3985 K951710 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH May 7, 1999
3988 K951710 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH May 7, 1999
4003 58188 Syva Emit st Drug Detection System 702 Benzodiazepines 7 HIGH July 26, 1993
4004 58190 Syva Qstat/Qst System 702 Benzodiazepines 7 HIGH July 26, 1993
4019 K923421 10205 Coulter Beta-2 Microglobulin EIA 703 Beta-2 microglobulin 3 HIGH November 22, 1993
4023 13109 Diagnostic Products Corp. Coat-A-Count IRMA 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4024 13111 Diagnostic Products Corp. Milenia 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4025 13165 Diagnostic Systems Beta2-Microglobin IEMA 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4026 13164 Diagnostic Systems Beta2-Microglobin RIA 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4033 K964767 55242 R & D Systems Quantikine IVD B-2 Microglobin EIA 703 Beta-2 microglobulin 3 HIGH July 18, 1997
4035 K946070 55207 Roche Diagnostics Cobas Bio {without DENS} (manual data reduction) 703 Beta-2 microglobulin 3 HIGH July 12, 1996
4038 58153 Serex Beta-2 Microglobulin EIA Kit 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4039 61120 T Cell Diagnostics CELLFREE Beta-2 M Test Kit 703 Beta-2 microglobulin 3 HIGH September 1, 1994
4046 K946068 61233 The Binding Site B2 Microglobulin RID 703 Beta-2 microglobulin 3 HIGH April 26, 1996
4047 61074 The Binding Site Human Beta-2 Microglobulin EL RID 703 Beta-2 microglobulin 3 HIGH July 26, 1993
4049 70158 Wallac Oy DELFIA B-2 Micro Kit 703 Beta-2 microglobulin 3 HIGH September 1, 1994
4050 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 732 Beta-Alanine 2 HIGH November 10, 1994
4051 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 732 Beta-Alanine 2 HIGH May 26, 1995
4052 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 733 Beta-Aminoisobutyric Acid 2 HIGH November 10, 1994
4053 58051 Sigma Diagnostics Test Kit 723 Beta-Glucuronidase 2 HIGH July 26, 1993
4054 4035 Abbott Bichromatic ABA 100 722 Beta-Hydroxybutyrate 2 HIGH July 26, 1993
4066 16010 Electronucleonics FLEXIGEM 722 Beta-Hydroxybutyrate 2 HIGH July 26, 1993
4067 22140 GDS Diagnostics Enzymatic Test Kit 722 Beta-Hydroxybutyrate 2 HIGH July 26, 1993
4070 28183 Instrumentation Laboratory Multistat III 722 Beta-Hydroxybutyrate 2 HIGH July 26, 1993
4081 58051 Sigma Diagnostics Test Kit 722 Beta-Hydroxybutyrate 2 HIGH July 26, 1993
4086 13128 Diagnostica Stago ASSERACHROM B-TG 713 Beta-Thromboglobulin 4 HIGH July 26, 1993
4088 28172 Immunotech ENDAB EIA Kit 747 Bile Acids 2 HIGH July 26, 1993
4089 K980525 40329 Marukin Shoyu UBAS Assay (manual) 747 Bile Acids 2 HIGH April 23, 1999
4092 58051 Sigma Diagnostics Test Kit 747 Bile Acids 2 HIGH July 26, 1993
4093 K970120 61289 TECO Diagnostics Bile Acids Reagent Set (manual) 747 Bile Acids 2 HIGH June 6, 1997
4097 4035 Abbott Bichromatic ABA 100 704 Bilirubin, Direct 2 HIGH July 26, 1993
4098 4036 Abbott Bichromatic ABA 200 704 Bilirubin, Direct 2 HIGH July 26, 1993
4099 4267 Abbott Bichromatic ABA 50 704 Bilirubin, Direct 2 HIGH July 26, 1993
4109 4143 American Monitor KDA 704 Bilirubin, Direct 2 HIGH July 26, 1993
4110 4144 American Monitor Parallel 704 Bilirubin, Direct 2 HIGH July 26, 1993
4111 4275 Ames OPTIMATE 704 Bilirubin, Direct 2 HIGH July 26, 1993
4152 13216 DMA Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4160 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 704 Bilirubin, Direct 2 HIGH July 26, 1993
4173 16010 Electronucleonics FLEXIGEM 704 Bilirubin, Direct 2 HIGH July 26, 1993
4178 K930679 25151 Horizon Direct Bilirubin (manual) 704 Bilirubin, Direct 2 HIGH November 22, 1993
4185 28183 Instrumentation Laboratory Multistat III 704 Bilirubin, Direct 2 HIGH July 26, 1993
4186 28184 Instrumentation Laboratory Multistat III Plus 704 Bilirubin, Direct 2 HIGH July 26, 1993
4211 40126 Mallinckrodt Serometer 370 704 Bilirubin, Direct 2 HIGH July 26, 1993
4212 40123 Medical Analysis Systems Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4213 40118 Meditech Diagnostic System Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4239 55075 Reagents Applications RAICHEM Test Kit (manual) 704 Bilirubin, Direct 2 HIGH July 26, 1993
4258 58185 Seragen StatEase 704 Bilirubin, Direct 2 HIGH July 26, 1993
4259 58051 Sigma Diagnostics Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4260 58195 SmithKline ESKALAB-CCS 704 Bilirubin, Direct 2 HIGH July 26, 1993
4261 58210 Stanbio Premiere 704 Bilirubin, Direct 2 HIGH July 26, 1993
4262 58157 Stanbio Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4263 58229 Sterling Diagnostics Analyzer 2000 704 Bilirubin, Direct 2 HIGH July 26, 1993
4264 58230 Sterling Diagnostics Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4265 K963939 58443 Synermed Direct Bilirubin (manual) 704 Bilirubin, Direct 2 HIGH April 11, 1997
4267 K933026 58260 Synermed Test Kit 704 Bilirubin, Direct 2 HIGH May 20, 1994
4268 K881172 61401 TECO Diagnostics Direct Bilirubin Reagent Set (manual) 704 Bilirubin, Direct 2 HIGH March 26, 1999
4269 K882938 61377 TECO Diagnostics TC 84 704 Bilirubin, Direct 2 HIGH November 19, 1998
4270 61044 TRACE Scientific Test Kit 704 Bilirubin, Direct 2 HIGH July 26, 1993
4280 61014 Technicon SMA 12/60 704 Bilirubin, Direct 2 HIGH July 26, 1993
4281 61016 Technicon SMAC 704 Bilirubin, Direct 2 HIGH July 26, 1993
4282 61045 Technicon SMAC 2 704 Bilirubin, Direct 2 HIGH July 26, 1993
4283 61046 Technicon SMAC 3 704 Bilirubin, Direct 2 HIGH July 26, 1993
4362 4035 Abbott Bichromatic ABA 100 706 Bilirubin, Total 2 HIGH July 26, 1993
4363 4036 Abbott Bichromatic ABA 200 706 Bilirubin, Total 2 HIGH July 26, 1993
4364 4267 Abbott Bichromatic ABA 50 706 Bilirubin, Total 2 HIGH July 26, 1993
4374 4143 American Monitor KDA 706 Bilirubin, Total 2 HIGH July 26, 1993
4375 4144 American Monitor Parallel 706 Bilirubin, Total 2 HIGH July 26, 1993
4377 4275 Ames OPTIMATE 706 Bilirubin, Total 2 HIGH July 26, 1993
4426 13216 DMA Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4435 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 706 Bilirubin, Total 2 HIGH July 26, 1993
4450 16010 Electronucleonics FLEXIGEM 706 Bilirubin, Total 2 HIGH July 26, 1993
4462 28183 Instrumentation Laboratory Multistat III 706 Bilirubin, Total 2 HIGH July 26, 1993
4463 28184 Instrumentation Laboratory Multistat III Plus 706 Bilirubin, Total 2 HIGH July 26, 1993
4494 40124 Medical Analysis Systems RefLab Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4495 40118 Meditech Diagnostic System Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4519 49064 Pointe Scientific 180 Chemistry Analyzer 706 Bilirubin, Total 2 HIGH July 26, 1993
4521 55075 Reagents Applications RAICHEM Test Kit (manual) 706 Bilirubin, Total 2 HIGH July 26, 1993
4547 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 706 Bilirubin, Total 2 HIGH July 26, 1993
4548 58186 Seragen Quick-Chem 706 Bilirubin, Total 2 HIGH July 26, 1993
4549 58051 Sigma Diagnostics Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4550 58195 SmithKline ESKALAB-CCS 706 Bilirubin, Total 2 HIGH July 26, 1993
4551 58210 Stanbio Premiere 706 Bilirubin, Total 2 HIGH July 26, 1993
4552 58229 Sterling Diagnostics Analyzer 2000 706 Bilirubin, Total 2 HIGH July 26, 1993
4553 58230 Sterling Diagnostics Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4555 K882938 61377 TECO Diagnostics TC 84 706 Bilirubin, Total 2 HIGH November 19, 1998
4556 K875069 61402 TECO Diagnostics Total Bilirubin Reagent Set (manual) 706 Bilirubin, Total 2 HIGH March 26, 1999
4557 61044 TRACE Scientific Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
4570 61014 Technicon SMA 12/60 706 Bilirubin, Total 2 HIGH July 26, 1993
4571 61016 Technicon SMAC 706 Bilirubin, Total 2 HIGH July 26, 1993
4572 61045 Technicon SMAC 2 706 Bilirubin, Total 2 HIGH July 26, 1993
4573 61046 Technicon SMAC 3 706 Bilirubin, Total 2 HIGH July 26, 1993
4582 K923859 40148 Meridian Diagnostics Premier Blastomyces EIA 724 Blastomyces Antibodies 3 HIGH November 22, 1993
4583 22133 Gen-Probe AccuProbe - B. dermatitidis (including culture) 707 Blastomyces dermatitidis 12 HIGH July 26, 1993
4584 28198 Immuno-Mycologics Exo-Antigen Test Kit (including culture) 707 Blastomyces dermatitidis 12 HIGH July 26, 1993
4600 10341 Chiron Diagnostics 168 708 Blood Gases 2 HIGH November 15, 1996
4614 10032 Ciba Corning 168 708 Blood Gases 2 HIGH July 26, 1993
4699 4102 All Anodic Stripping Voltametry Procedures 709 Blood Lead 7 HIGH July 26, 1993
4700 4104 All Atomic Absorption Test Systems 709 Blood Lead 7 HIGH July 26, 1993
4702 16020 esa Model 3010A Trace Metals Analyzer 709 Blood Lead 7 HIGH July 26, 1993
4703 16021 esa Model 3010B Lead Analyzer 709 Blood Lead 7 HIGH July 26, 1993
4704 4264 All Permanent Stain Preparations 710 Blood, Tissue & Intestinal Parasites 11 HIGH July 26, 1993
4711 13168 Difco FA Bordetella Pertussis/Parapertussis (direct Ag) 715 Bordetella pertussis/parapertussis 8 HIGH July 26, 1993
4712 13115 Difco FA Bordetella Pertussis/Parapertussis (including culture) 715 Bordetella pertussis/parapertussis 8 HIGH July 26, 1993
4715 13031 Diagnostic Products Corp. Double Antibody 1040 C-Peptide 2 HIGH July 26, 1993
4716 13187 Diagnostic Systems C-Peptide RIA Kit 1040 C-Peptide 2 HIGH July 26, 1993
4717 28204 Incstar C-Peptide 1040 C-Peptide 2 HIGH July 26, 1993
4718 E990027 34100 KMI Diagnostics C-Peptid(e) ELISA 1040 C-Peptide 2 HIGH March 26, 1999
4735 7383 Beckman Auto ICS 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4736 7381 Beckman ICS 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4737 7382 Beckman ICS II 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4778 K981871 13555 Diagnostic Systems Active C-Reactive Protein ELISA 1001 C-Reactive Protein (CRP) 3 HIGH May 24, 1999
4794 K944288 25172 Hemagen C-Reactive Protein Kit 1001 C-Reactive Protein (CRP) 3 HIGH November 23, 1994
4795 K960324 25256 Hemagen CRP 150 EIA 1001 C-Reactive Protein (CRP) 3 HIGH April 5, 1996
4796 25024 Hycor Accuplate 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4799 28183 Instrumentation Laboratory Multistat III 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4806 34010 Kent Radial Immunodiffusion Test 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4818 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4846 61091 The Binding Site C-Reactive Protein (turbidimetric) 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4847 61075 The Binding Site Human C-Reactive Protein EL RID 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4848 K973692 64039 United Biotech UBI MAGIWEL CRP Quantitative 1001 C-Reactive Protein (CRP) 3 HIGH April 10, 1998
4851 70102 Wako Autokit 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
4855 K951967 34010 Kent Radial Immunodiffusion Test 1051 C1-Esterase Inhibitor (C1INH) 3 HIGH July 28, 1995
4856 43054 Nyegaard Nycotest C1-Esterase Inhibitor 1051 C1-Esterase Inhibitor (C1INH) 3 HIGH July 26, 1993
4857 K925255 61195 T Cell Diagnostics TRAx CD4 Test Kit 1124 CD4 Protein 3 HIGH May 19, 1995
4871 K982491 4838 Alfa Scientific Designs Calcitonin ELISA 1041 Calcitonin 6 HIGH July 23, 1999
4872 K951708 10312 CIS-US ELSA-hCT 1041 Calcitonin 6 HIGH September 8, 1995
4873 13031 Diagnostic Products Corp. Double Antibody 1041 Calcitonin 6 HIGH July 26, 1993
4874 13112 Diagnostic Products Corp. Solid Phase 1041 Calcitonin 6 HIGH July 26, 1993
4875 13184 Diagnostic Systems Calcitonin RIA Kit 1041 Calcitonin 6 HIGH July 26, 1993
4876 13199 Diagnostic Systems Ultra-Sensitive Calcitonin RIA Kit 1041 Calcitonin 6 HIGH July 26, 1993
4877 28211 Incstar Calcitonin II 1041 Calcitonin 6 HIGH July 26, 1993
4878 K990073 34115 KMI Diagnostics Calcitonin ELISA 1041 Calcitonin 6 HIGH October 8, 1999
4880 K945961 43113 Nichols Institute Chemiluminescence Calcitonin Assay 1041 Calcitonin 6 HIGH March 1, 1996
4881 43044 Nichols Institute RIA Kit 1041 Calcitonin 6 HIGH July 26, 1993
4882 K982491 58538 Sangui BioTech Calcitonin ELISA 1041 Calcitonin 6 HIGH October 30, 1998
4959 4035 Abbott Bichromatic ABA 100 1005 Calcium, Total 2 HIGH July 26, 1993
4960 4036 Abbott Bichromatic ABA 200 1005 Calcium, Total 2 HIGH July 26, 1993
4961 4267 Abbott Bichromatic ABA 50 1005 Calcium, Total 2 HIGH July 26, 1993
4972 4144 American Monitor Parallel 1005 Calcium, Total 2 HIGH July 26, 1993
4973 4275 Ames OPTIMATE 1005 Calcium, Total 2 HIGH July 26, 1993
5018 13216 DMA Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5027 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1005 Calcium, Total 2 HIGH July 26, 1993
5041 16010 Electronucleonics FLEXIGEM 1005 Calcium, Total 2 HIGH July 26, 1993
5046 K880845 25208 Horizon Calcium (Liquid) (manual) 1005 Calcium, Total 2 HIGH April 28, 1995
5047 28157 Instrumentation Laboratory IL 504 1005 Calcium, Total 2 HIGH July 26, 1993
5048 28158 Instrumentation Laboratory IL 508 1005 Calcium, Total 2 HIGH July 26, 1993
5055 28183 Instrumentation Laboratory Multistat III 1005 Calcium, Total 2 HIGH July 26, 1993
5056 28184 Instrumentation Laboratory Multistat III Plus 1005 Calcium, Total 2 HIGH July 26, 1993
5087 40126 Mallinckrodt Serometer 370 1005 Calcium, Total 2 HIGH July 26, 1993
5088 40118 Meditech Diagnostic System Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5117 49064 Pointe Scientific 180 Chemistry Analyzer 1005 Calcium, Total 2 HIGH July 26, 1993
5120 55075 Reagents Applications RAICHEM Test Kit (manual) 1005 Calcium, Total 2 HIGH July 26, 1993
5143 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 1005 Calcium, Total 2 HIGH July 26, 1993
5144 58187 Seradyn Quick-Chem II 1005 Calcium, Total 2 HIGH July 26, 1993
5145 58165 Sherwood Medical Rapid Stat Diagnostic Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5146 58051 Sigma Diagnostics Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5147 58195 SmithKline ESKALAB-CCS 1005 Calcium, Total 2 HIGH July 26, 1993
5148 58210 Stanbio Premiere 1005 Calcium, Total 2 HIGH July 26, 1993
5149 58157 Stanbio Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5150 58229 Sterling Diagnostics Analyzer 2000 1005 Calcium, Total 2 HIGH July 26, 1993
5151 K953395 58375 Synermed Calcium (manual) 1005 Calcium, Total 2 HIGH September 8, 1995
5154 K864741 61404 TECO Diagnostics Calcium Reagent Set (manual) 1005 Calcium, Total 2 HIGH March 26, 1999
5155 K882938 61377 TECO Diagnostics TC 84 1005 Calcium, Total 2 HIGH November 19, 1998
5156 61044 TRACE Scientific Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5167 61014 Technicon SMA 12/60 1005 Calcium, Total 2 HIGH July 26, 1993
5168 61016 Technicon SMAC 1005 Calcium, Total 2 HIGH July 26, 1993
5169 61045 Technicon SMAC 2 1005 Calcium, Total 2 HIGH July 26, 1993
5170 61046 Technicon SMAC 3 1005 Calcium, Total 2 HIGH July 26, 1993
5172 70108 Wako Calcium C Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
5175 K982315 4814 Alexon-Trend ProSpecT Campylobacter Microplate Assay (spectrophotometric) 1006 Campylobacter 8 HIGH February 5, 1999
5176 K982315 4815 Alexon-Trend ProSpecT Campylobacter Microplate Assay (visual) 1006 Campylobacter 8 HIGH February 5, 1999
5177 22040 Gen-Probe AccuProbe (including culture) 1006 Campylobacter 8 HIGH July 26, 1993
5178 40067 Meridian Diagnostics Meritec-Campy(JCL) (including culture) 1006 Campylobacter 8 HIGH July 26, 1993
5179 4276 Abbott CA 125 RIA 1049 Cancer Antigen 125 (CA 125) 2 HIGH July 26, 1993
5193 K965141 8025 BIOMIRA Diagnostics TRUQUANT BR RIA 1132 Cancer Antigen 27.29 (CA 27.29) 2 HIGH January 23, 1998
5197 28025 Immuno-Mycologics Candi-Sphere EIA (CEIA) 1008 Candida albicans Antibodies 3 HIGH July 26, 1993
5198 28027 Immuno-Mycologics ID-Candida Antibody System 1008 Candida albicans Antibodies 3 HIGH July 26, 1993
5199 40060 Meridian Diagnostics Candida Immunodiffusion System 1008 Candida albicans Antibodies 3 HIGH July 26, 1993
5213 4275 Ames OPTIMATE 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5220 K944562 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5225 K944562 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5229 K944562 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5234 K944562 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH April 10, 1998
5245 K935591 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5249 K935591 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5256 K944562 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
5270 13031 Diagnostic Products Corp. Double Antibody 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5271 13111 Diagnostic Products Corp. Milenia 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5288 19013 Finnigan MAT Witness System 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5300 28175 Immunotech Microzyme EIA (spectrophotometric) 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5305 28183 Instrumentation Laboratory Multistat III 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5306 28184 Instrumentation Laboratory Multistat III Plus 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5318 K945207 40234 Meco Industries MECTEST Cannabinoid Radioimmunoassay 1009 Cannabinoids (THC) 7 HIGH October 27, 1995
5355 55098 Roche Diagnostics Abuscreen RIA 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5368 K935591 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH May 7, 1999
5370 K935591 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH May 7, 1999
5377 K944562 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH May 7, 1999
5389 K924815 58292 STC Technologies Cannabinoids EIA Plate Kit 1009 Cannabinoids (THC) 7 HIGH November 22, 1993
5392 K973750 58504 STC Technologies Cannabinoids Micro-Plate EIA {EpiScreen Oral Fluid Specimens} 1009 Cannabinoids (THC) 7 HIGH April 24, 1998
5393 58104 Sigma Diagnostics SIA THC 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5402 58188 Syva Emit st Drug Detection System 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5405 61059 TOXI-LAB Cannabinoid (THC) Screen 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5406 61061 TOXI-LAB THC II 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5407 61062 TOXI-LAB THC II-PLUS 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
5412 K940912 64026 USDT Flow Immunoassay System 1009 Cannabinoids (THC) 7 HIGH September 15, 1994
5413 K973154 64048 United Biotech UBI MAGIWEL ELISA for Marijuana Metabolites 1009 Cannabinoids (THC) 7 HIGH November 6, 1998
5423 4275 Ames OPTIMATE 1010 Carbamazepine 7 HIGH July 26, 1993
5425 4156 Ames TDA 1010 Carbamazepine 7 HIGH July 26, 1993
5431 7383 Beckman Auto ICS 1010 Carbamazepine 7 HIGH July 26, 1993
5432 7381 Beckman ICS 1010 Carbamazepine 7 HIGH July 26, 1993
5433 7382 Beckman ICS II 1010 Carbamazepine 7 HIGH July 26, 1993
5484 28183 Instrumentation Laboratory Multistat III 1010 Carbamazepine 7 HIGH July 26, 1993
5485 28184 Instrumentation Laboratory Multistat III Plus 1010 Carbamazepine 7 HIGH July 26, 1993
5515 58082 Syva Emit Test Kit 1010 Carbamazepine 7 HIGH July 26, 1993
5516 58190 Syva Qstat/Qst System 1010 Carbamazepine 7 HIGH July 26, 1993
5522 58082 Syva Emit Test Kit 1011 Carbamazepine, Free 7 HIGH July 26, 1993
5523 K990931 19054 Finnigan BreathMAT Plus Isotope Ratio Mass Spectrometer {Metabolic Solutions Ez-HBT Helicobacter Blood Test} 1150 Carbon Dioxide, Isotope 13 2 HIGH January 26, 2000
5528 4035 Abbott Bichromatic ABA 100 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5529 4267 Abbott Bichromatic ABA 50 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5540 4275 Ames OPTIMATE 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5547 7378 Beckman Manual Spectrophotometric Test Procedure 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5585 13216 DMA Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5594 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5616 28183 Instrumentation Laboratory Multistat III 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5617 28184 Instrumentation Laboratory Multistat III Plus 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5619 K932267 28321 Intersect Systems Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH October 14, 1994
5647 40123 Medical Analysis Systems Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5677 49064 Pointe Scientific 180 Chemistry Analyzer 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5678 K951221 55201 Randox Laboratories CO2 (TOTAL) (manual) 1003 Carbon Dioxide, Total (CO2) 2 HIGH April 26, 1996
5679 55075 Reagents Applications RAICHEM Test Kit (manual) 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5700 58051 Sigma Diagnostics Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5701 58157 Stanbio Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5702 58229 Sterling Diagnostics Analyzer 2000 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5704 58260 Synermed Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5705 K942735 61150 TECO Diagnostics Carbon Dioxide (manual) 1003 Carbon Dioxide, Total (CO2) 2 HIGH March 24, 1995
5706 K882938 61377 TECO Diagnostics TC 84 1003 Carbon Dioxide, Total (CO2) 2 HIGH November 19, 1998
5707 K952410 61212 TRACE Scientific CO2-DST (manual) 1003 Carbon Dioxide, Total (CO2) 2 HIGH October 20, 1995
5708 61044 TRACE Scientific Test Kit 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5718 61015 Technicon SMA 6/60 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5719 61016 Technicon SMAC 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5720 61045 Technicon SMAC 2 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5721 61046 Technicon SMAC 3 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
5750 4037 Abbott CEA-EIA Monoclonal 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5751 4038 Abbott CEA-EIA One-Step 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5752 4334 Abbott COMMANDER System 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5753 4062 Abbott RIA Monoclonal 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5762 25022 Hybritech Tandem-E 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5763 25023 Hybritech Tandem-R 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5765 55102 Roche Diagnostics CEA-Roche EIA 1013 Carcinoembryonic Antigen (CEA) 2 HIGH July 26, 1993
5774 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 1108 Carnosine 2 HIGH November 10, 1994
5776 7279 Bio-Rad HPLC 1056 Catecholamines, Plasma 6 HIGH July 26, 1993
5777 7300 Bioanalytical Systems BAS 200A 1056 Catecholamines, Plasma 6 HIGH July 26, 1993
5778 7301 Bioanalytical Systems BAS 480 1056 Catecholamines, Plasma 6 HIGH July 26, 1993
5779 7302 Bioanalytical Systems BAS 481 1056 Catecholamines, Plasma 6 HIGH July 26, 1993
5780 7307 Bioanalytical Systems BAS 482 1056 Catecholamines, Plasma 6 HIGH July 26, 1993
5781 7279 Bio-Rad HPLC 1055 Catecholamines, Urine 6 HIGH July 26, 1993
5782 K942451 7778 Bio-Rad MDMS/CDMS 1055 Catecholamines, Urine 6 HIGH June 7, 1996
5783 K943099 7560 Bioanalytical Systems Urinary Catecholamine Kit 1055 Catecholamines, Urine 6 HIGH November 23, 1994
5796 7278 Bio-Rad Test Kit 1014 Cerebrospinal Fluid (CSF) Protein 2 HIGH July 26, 1993
5802 13216 DMA Test Kit 1014 Cerebrospinal Fluid (CSF) Protein 2 HIGH July 26, 1993
5850 K951222 55106 Randox Laboratories Test Kit 1014 Cerebrospinal Fluid (CSF) Protein 2 HIGH April 26, 1996
5859 58157 Stanbio Test Kit 1014 Cerebrospinal Fluid (CSF) Protein 2 HIGH July 26, 1993
5860 4363 All Manual Cerebrospinal Fluid Cell Count Procedures 1061 Cerebrospinal Fluid Microscopic Elements 4 HIGH July 26, 1993
5861 7370 Beckman Paragon HRE Electrophoresis Kit 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
5862 7374 Beckman Paragon Immunoelectrophoresis (IEP) Kit 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
5863 7369 Beckman Paragon SPE Electrophoresis Kit 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
5864 7368 Beckman Paragon SPE-II Electrophoresis Kit 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
5865 28187 Isolab Resolve-CSF 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
5866 K981048 58596 Sebia HYDRASYS {Hydragel 6 CSF} 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH January 26, 2000
5867 K982450 58598 Sebia HYDRASYS {Hydragel 7/15 HR} 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH January 26, 2000
5868 K982450 58600 Sebia Hydragel -Mini HR/HR Kit (manual) 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH January 26, 2000
5871 7383 Beckman Auto ICS 1015 Ceruloplasmin 2 HIGH July 26, 1993
5872 7381 Beckman ICS 1015 Ceruloplasmin 2 HIGH July 26, 1993
5873 7382 Beckman ICS II 1015 Ceruloplasmin 2 HIGH July 26, 1993
5879 7119 Behring Nor-partigen Kit 1015 Ceruloplasmin 2 HIGH July 26, 1993
5880 28183 Instrumentation Laboratory Multistat III 1015 Ceruloplasmin 2 HIGH July 26, 1993
5881 34010 Kent Radial Immunodiffusion Test 1015 Ceruloplasmin 2 HIGH July 26, 1993
5889 61081 The Binding Site Human Caeruloplasmin RID 1015 Ceruloplasmin 2 HIGH July 26, 1993
5890 4002 ADI Visuwell Chlamydia (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5891 4334 Abbott COMMANDER System 1016 Chlamydia 8 HIGH July 26, 1993
5892 4260 Abbott Chlamydiazyme (with blocking reagent) 1016 Chlamydia 8 HIGH July 26, 1993
5893 4044 Abbott Chlamydiazyme EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5894 K936054 4229 Abbott IMX Select 1016 Chlamydia 8 HIGH June 7, 1996
5895 K934622 4541 Abbott LCx Chlamydia trachomatis Assay 1016 Chlamydia 8 HIGH December 15, 1995
5897 4331 All Organism Identification from Cell Culture 1016 Chlamydia 8 HIGH July 26, 1993
5898 K861966 4300 Analytab API IDEIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5899 K861966 4213 Analytab API IDEIA (direct Ag/visual) 1016 Chlamydia 8 HIGH July 26, 1993
5900 K864539 4214 Analytab API IMAGEN Chlamydia (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5901 7026 Baxter Bartels Chlamydia EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5902 7027 Baxter Bartels Chlamydiae FA Monoclonal (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5903 7028 Baxter Bartels Chlamydiae Immunoperoxidase (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5905 10028 Cellabs Diagnostics Chlamydia-Cel TWAR IFA (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5906 10056 Ciba Corning Magic Lite Chlamydia (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5907 10184 Ciba Corning Magic Lite Chlamydia (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5908 10179 Ciba Corning Magic Lite Chlamydia (with blocking reagent) 1016 Chlamydia 8 HIGH July 26, 1993
5909 K861966 13329 DAKO IDEIA Chlamydia (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH March 3, 1995
5910 K861966 13328 DAKO IDEIA Chlamydia (direct Ag/visual) 1016 Chlamydia 8 HIGH March 3, 1995
5911 K940564 13322 DAKO IDEIA Chlamydia Blocking Reagents 1016 Chlamydia 8 HIGH January 19, 1996
5912 K864539 13334 DAKO IMAGEN Chlamydia (direct Ag) 1016 Chlamydia 8 HIGH March 3, 1995
5913 13125 Diagnostic Products Corp. PDx Chlamydia Culture Confirmation (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5914 13035 Diagnostic Products PathoDx Chlamydia trachomatis (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5915 13167 Diagnostic Technology Chlamydia-Check System (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5916 13219 Diagnostic Technology Chlamydia-Check System (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5917 13060 Difco Chlamydia Direct Detection System (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5918 K962217 22186 Gen-Probe AMPLIFIED Chlamydia Trachomatis Assay 1016 Chlamydia 8 HIGH April 4, 1997
5919 K940979 22171 Gen-Probe PACE 2C System 1016 Chlamydia 8 HIGH November 10, 1994
5920 22041 Gen-Probe Pace2 (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5921 K912680 28586 INTRACEL Bartels Chlamydia EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH January 18, 2000
5922 K864389 28587 INTRACEL Bartels Chlamydiae FA Monoclonal (including cell culture) 1016 Chlamydia 8 HIGH January 18, 2000
5923 K842151 28588 INTRACEL Bartels Chlamydiae Immunoperoxidase (including cell culture) 1016 Chlamydia 8 HIGH January 18, 2000
5924 28039 Incstar Chlamydia Direct Test System (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5926 K941714 43099 NeoGenex C. trachomatis Antigen Test (direct Ag) 1016 Chlamydia 8 HIGH October 14, 1994
5927 K941714 43098 NeoGenex C. trachomatis Antigen Test (including cell culture) 1016 Chlamydia 8 HIGH October 14, 1994
5928 46052 Ortho Chlamydia (DFA) (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5929 46053 Ortho Chlamydia Antigen ELISA Test (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5930 46125 Ortho Chlamydia Antigen ELISA Test (including cell culture/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5931 46054 Ortho Cultureset Chlamydia ID Kit (FA) (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5932 46055 Ortho Cultureset Chlamydia ID Kit (PAP) (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5934 K973707 55669 Roche Diagnostics AMPLICOR CT/NG Test for Chlamydia trachomatis 1016 Chlamydia 8 HIGH January 7, 2000
5935 K922906 55118 Roche Diagnostics AMPLICOR Chlamydia Trachomatis Test 1016 Chlamydia 8 HIGH November 22, 1993
5936 K964507 55253 Roche Diagnostics COBAS AMPLICOR Analyzer 1016 Chlamydia 8 HIGH August 29, 1997
5937 K935807 58257 Sanofi Pasteur Access Immunoassay System 1016 Chlamydia 8 HIGH May 26, 1995
5938 K935393 58336 Sanofi Pasteur Chlamydia Microplate EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH October 28, 1994
5939 K935393 58330 Sanofi Pasteur Chlamydia Microplate EIA Blocking (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH October 28, 1994
5940 58002 Sanofi/Kallestad Pathfinder (FA) (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5941 58220 Sanofi/Kallestad Pathfinder Chlamydia EIA Detection Kit 1016 Chlamydia 8 HIGH July 26, 1993
5942 58018 Scimedx Chlamydia Test Kit (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5944 58093 Sigma Diagnostics SIA Chlamydia (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5945 58084 Syva MicroTrak Chlamydia EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5946 58085 Syva MicroTrak Culture Confirmation IF Test (including cell culture) 1016 Chlamydia 8 HIGH July 26, 1993
5947 58086 Syva MicroTrak Direct Specimen IF System (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5948 58262 Syva MicroTrak II Chlamydia EIA (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
5949 58263 Syva MicroTrak XL 1016 Chlamydia 8 HIGH July 26, 1993
5951 K955627 67102 Vitek Systems VIDAS Chlamydia Blocking Assay 1016 Chlamydia 8 HIGH November 15, 1996
5952 67038 Vitek Systems Vidas 1016 Chlamydia 8 HIGH July 26, 1993
5954 70022 Wellcome Chlamyset (direct Ag) 1016 Chlamydia 8 HIGH July 26, 1993
5955 7806 bioMerieux Vitek VIDAS 1016 Chlamydia 8 HIGH October 25, 1996
5956 K955627 7825 bioMerieux Vitek VIDAS Chlamydia Blocking Assay 1016 Chlamydia 8 HIGH November 15, 1996
5957 K962558 70212 Wampole Chlamydia IgG ELISA 1139 Chlamydia Antibodies, species non-specific 3 HIGH January 23, 1998
5963 4159 Amico Amizyme Chlamydia trachomatis Antibody Test 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5964 7319 BioWhittaker CHLAMYDELISA II 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5965 7320 BioWhittaker CHLAMYDIA STAT 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5966 28042 Incstar Fluoro-Kit 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5969 58091 Serono Baker Serozyme 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5970 58251 Serono Diagnostics Serozyme 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5971 67018 Virgo Chlamydia trachomatis IFA Test 1017 Chlamydia trachomatis Antibodies 3 HIGH July 26, 1993
5976 58082 Syva Emit Test Kit 1063 Chloramphenicol 7 HIGH July 26, 1993
5987 4036 Abbott Bichromatic ABA 200 1018 Chloride 2 HIGH July 26, 1993
5988 4267 Abbott Bichromatic ABA 50 1018 Chloride 2 HIGH July 26, 1993
5997 4275 Ames OPTIMATE 1018 Chloride 2 HIGH July 26, 1993
6031 7312 Buchler Digital Chloridometer 1018 Chloride 2 HIGH July 26, 1993
6057 13216 DMA Test Kit 1018 Chloride 2 HIGH July 26, 1993
6067 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1018 Chloride 2 HIGH July 26, 1993
6078 16010 Electronucleonics FLEXIGEM 1018 Chloride 2 HIGH July 26, 1993
6083 K881240 25209 Horizon Chloride (manual) 1018 Chloride 2 HIGH April 28, 1995
6088 28158 Instrumentation Laboratory IL 508 1018 Chloride 2 HIGH July 26, 1993
6097 28183 Instrumentation Laboratory Multistat III 1018 Chloride 2 HIGH July 26, 1993
6098 28184 Instrumentation Laboratory Multistat III Plus 1018 Chloride 2 HIGH July 26, 1993
6117 K922921 34051 King Diagnostics Test Kit 1018 Chloride 2 HIGH July 26, 1993
6128 40126 Mallinckrodt Serometer 370 1018 Chloride 2 HIGH July 26, 1993
6133 40124 Medical Analysis Systems RefLab Test Kit 1018 Chloride 2 HIGH July 26, 1993
6134 40118 Meditech Diagnostic System Test Kit 1018 Chloride 2 HIGH July 26, 1993
6182 49064 Pointe Scientific 180 Chemistry Analyzer 1018 Chloride 2 HIGH July 26, 1993
6218 58051 Sigma Diagnostics Test Kit 1018 Chloride 2 HIGH July 26, 1993
6219 58195 SmithKline ESKALAB-CCS 1018 Chloride 2 HIGH July 26, 1993
6220 58210 Stanbio Premiere 1018 Chloride 2 HIGH July 26, 1993
6221 58157 Stanbio Test Kit 1018 Chloride 2 HIGH July 26, 1993
6222 58229 Sterling Diagnostics Analyzer 2000 1018 Chloride 2 HIGH July 26, 1993
6224 61044 TRACE Scientific Test Kit 1018 Chloride 2 HIGH July 26, 1993
6237 61015 Technicon SMA 6/60 1018 Chloride 2 HIGH July 26, 1993
6238 61016 Technicon SMAC 1018 Chloride 2 HIGH July 26, 1993
6239 61045 Technicon SMAC 2 1018 Chloride 2 HIGH July 26, 1993
6242 4096 Advanced Instruments Cystic Fibrosis Analyzer 1019 Chloride, Sweat (Cystic Fibrosis Sweat Test) 2 HIGH July 26, 1993
6243 46121 Orion Diagnostica Model 417 Skin Chloride System 1019 Chloride, Sweat (Cystic Fibrosis Sweat Test) 2 HIGH July 26, 1993
6245 70104 Wescor 3100 Sweat.Chek Sweat Conductivity Analyzer 1019 Chloride, Sweat (Cystic Fibrosis Sweat Test) 2 HIGH July 26, 1993
6248 4035 Abbott Bichromatic ABA 100 1020 Cholesterol 2 HIGH July 26, 1993
6249 4036 Abbott Bichromatic ABA 200 1020 Cholesterol 2 HIGH July 26, 1993
6250 4267 Abbott Bichromatic ABA 50 1020 Cholesterol 2 HIGH July 26, 1993
6265 4144 American Monitor Parallel 1020 Cholesterol 2 HIGH July 26, 1993
6267 4275 Ames OPTIMATE 1020 Cholesterol 2 HIGH July 26, 1993
6275 7378 Beckman Manual Spectrophotometric Test Procedure 1020 Cholesterol 2 HIGH July 26, 1993
6321 13216 DMA Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
6332 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1020 Cholesterol 2 HIGH July 26, 1993
6351 K880273 25210 Horizon Cholesterol (manual) 1020 Cholesterol 2 HIGH April 28, 1995
6359 28183 Instrumentation Laboratory Multistat III 1020 Cholesterol 2 HIGH July 26, 1993
6360 28184 Instrumentation Laboratory Multistat III Plus 1020 Cholesterol 2 HIGH July 26, 1993
6379 K923128 34051 King Diagnostics Test Kit 1020 Cholesterol 2 HIGH September 15, 1994
6393 40126 Mallinckrodt Serometer 370 1020 Cholesterol 2 HIGH July 26, 1993
6395 40118 Meditech Diagnostic System Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
6419 49064 Pointe Scientific 180 Chemistry Analyzer 1020 Cholesterol 2 HIGH July 26, 1993
6423 K923504 55106 Randox Laboratories Test Kit 1020 Cholesterol 2 HIGH June 10, 1994
6424 55075 Reagents Applications RAICHEM Test Kit (manual) 1020 Cholesterol 2 HIGH July 26, 1993
6453 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 1020 Cholesterol 2 HIGH July 26, 1993
6454 58187 Seradyn Quick-Chem II 1020 Cholesterol 2 HIGH July 26, 1993
6455 58186 Seragen Quick-Chem 1020 Cholesterol 2 HIGH July 26, 1993
6456 58185 Seragen StatEase 1020 Cholesterol 2 HIGH July 26, 1993
6457 58164 Sherwood Medical Auto/Stat Kit 1020 Cholesterol 2 HIGH July 26, 1993
6458 58051 Sigma Diagnostics Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
6459 58195 SmithKline ESKALAB-CCS 1020 Cholesterol 2 HIGH July 26, 1993
6460 58210 Stanbio Premiere 1020 Cholesterol 2 HIGH July 26, 1993
6461 58157 Stanbio Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
6462 58229 Sterling Diagnostics Analyzer 2000 1020 Cholesterol 2 HIGH July 26, 1993
6463 K863927 61406 TECO Diagnostics Cholesterol Reagent Set (manual) 1020 Cholesterol 2 HIGH March 26, 1999
6464 K882938 61377 TECO Diagnostics TC 84 1020 Cholesterol 2 HIGH November 19, 1998
6465 61044 TRACE Scientific Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
6476 61014 Technicon SMA 12/60 1020 Cholesterol 2 HIGH July 26, 1993
6477 61016 Technicon SMAC 1020 Cholesterol 2 HIGH July 26, 1993
6478 61045 Technicon SMAC 2 1020 Cholesterol 2 HIGH July 26, 1993
6479 61046 Technicon SMAC 3 1020 Cholesterol 2 HIGH July 26, 1993
6481 70113 Wako Autokit Cholesterol COD-MEHA Method 1020 Cholesterol 2 HIGH July 26, 1993
6482 70106 Wako Cholesterol CII Assay Kit 1020 Cholesterol 2 HIGH July 26, 1993
6508 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1021 Cholinesterase 2 HIGH July 26, 1993
6511 16010 Electronucleonics FLEXIGEM 1021 Cholinesterase 2 HIGH July 26, 1993
6522 28183 Instrumentation Laboratory Multistat III 1021 Cholinesterase 2 HIGH July 26, 1993
6523 28184 Instrumentation Laboratory Multistat III Plus 1021 Cholinesterase 2 HIGH July 26, 1993
6577 58051 Sigma Diagnostics Test Kit 1021 Cholinesterase 2 HIGH July 26, 1993
6578 K914171 61407 TECO Diagnostics Cholinesterase (PTC) Reagent Set (manual) 1021 Cholinesterase 2 HIGH March 26, 1999
6584 4035 Abbott Bichromatic ABA 100 1053 Cholyglycine 2 HIGH July 26, 1993
6585 4517 Abbott CG RIA Kit 1053 Cholyglycine 2 HIGH September 1, 1994
6599 28183 Instrumentation Laboratory Multistat III 1053 Cholyglycine 2 HIGH July 26, 1993
6600 28184 Instrumentation Laboratory Multistat III Plus 1053 Cholyglycine 2 HIGH July 26, 1993
6614 K962873 67105 Vysis CEP 12 SpectrumOrange DNA Probe Kit for FISH 1146 Chromosome 12 2 HIGH February 6, 1998
6615 K972200 67103 Vysis AneuVysion Multicolor DNA Probe (CEP18/X/Y,LSI 13/21) 1140 Chromosome 13 2 HIGH February 6, 1998
6616 K972200 67103 Vysis AneuVysion Multicolor DNA Probe (CEP18/X/Y,LSI 13/21) 1141 Chromosome 18 2 HIGH February 6, 1998
6617 K972200 67103 Vysis AneuVysion Multicolor DNA Probe (CEP18/X/Y,LSI 13/21) 1142 Chromosome 21 2 HIGH February 6, 1998
6618 K953591 67104 Vysis CEP 8 SpectrumOrange DNA Probe Kit for FISH 1145 Chromosome 8 2 HIGH February 6, 1998
6619 K972200 67103 Vysis AneuVysion Multicolor DNA Probe (CEP18/X/Y,LSI 13/21) 1143 Chromosome X 2 HIGH February 6, 1998
6620 K954214 67106 Vysis CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit for FISH 1143 Chromosome X 2 HIGH February 6, 1998
6621 K972200 67103 Vysis AneuVysion Multicolor DNA Probe (CEP18/X/Y,LSI 13/21) 1144 Chromosome Y 2 HIGH February 6, 1998
6622 K954214 67106 Vysis CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit for FISH 1144 Chromosome Y 2 HIGH February 6, 1998
6623 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 1105 Citrulline 2 HIGH November 10, 1994
6624 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 1105 Citrulline 2 HIGH May 26, 1995
6625 4094 Advanced Clinical Diagnostic CDT Toxi Test (direct Ag) 1022 Clostridium difficile 8 HIGH July 26, 1993
6626 K934493 4540 Alexon-Trend ProSpecT Clostridium difficile (direct Ag/spectrophotometric) 1022 Clostridium difficile 8 HIGH November 10, 1994
6627 K934493 4539 Alexon-Trend ProSpecT Clostridium difficile (direct Ag/visual) 1022 Clostridium difficile 8 HIGH November 10, 1994
6628 K964864 4683 Alexon-Trend ProspecT II C.difficile Toxin A (spectrophotometric) 1022 Clostridium difficile 8 HIGH February 14, 1997
6629 K964864 4682 Alexon-Trend ProspecT II C.difficile Toxin A (visual) 1022 Clostridium difficile 8 HIGH February 14, 1997
6630 4333 Analytab C. difficile A+B ELISA Test Kit (direct Ag) 1022 Clostridium difficile 8 HIGH July 26, 1993
6631 7024 Baxter Bartels C. difficile Toxin A EIA (direct Ag) 1022 Clostridium difficile 8 HIGH July 26, 1993
6632 7029 Baxter Bartels Cytotoxicity Assay for C. difficile (direct Ag) 1022 Clostridium difficile 8 HIGH July 26, 1993
6633 K925329 7487 Becton Dickinson CULTURETTE BRAND Toxin CD (direct Ag/spectrophotometric) 1022 Clostridium difficile 8 HIGH November 22, 1993
6634 K925329 7486 Becton Dickinson CULTURETTE BRAND Toxin CD (direct Ag/visual) 1022 Clostridium difficile 8 HIGH November 22, 1993
6636 K980185 8171 Becton Dickinson ColorPAC Toxin A Test (including culture) 1022 Clostridium difficile 8 HIGH April 9, 1999
6639 7432 BioWhittaker TOX-A Test (direct Ag/spectrophotometric) 1022 Clostridium difficile 8 HIGH July 26, 1993
6640 7433 BioWhittaker TOX-A Test (direct Ag/visual) 1022 Clostridium difficile 8 HIGH July 26, 1993
6642 10007 Cambridge Biotech Cytoclone A & B EIA (direct Ag) 1022 Clostridium difficile 8 HIGH July 26, 1993
6643 K990664 28576 INTRACEL Bartels C. difficile Toxin A EIA 1022 Clostridium difficile 8 HIGH December 22, 1999
6644 K904329 28584 INTRACEL Bartels C. difficile Toxin A EIA (direct Ag) 1022 Clostridium difficile 8 HIGH January 18, 2000
6645 K833447 28589 INTRACEL Bartels Cytotoxicity Assay for C. difficile (direct Ag) 1022 Clostridium difficile 8 HIGH January 18, 2000
6649 K993914 40345 Meridian Diagnostics Premier Toxins A & B (direct antigen/spectrophotometric) 1022 Clostridium difficile 8 HIGH December 22, 1999
6650 K993914 40344 Meridian Diagnostics Premier Toxins A & B (direct antigen/visual) 1022 Clostridium difficile 8 HIGH December 22, 1999
6651 K931129 61149 TechLab C. difficile 1-hour TOX-A Test (spectrophotometric) 1022 Clostridium difficile 8 HIGH September 15, 1994
6652 K931129 61148 TechLab C. difficile 1-hour TOX-A Test (visual) 1022 Clostridium difficile 8 HIGH September 15, 1994
6653 K923463 61107 TechLab C. difficile Toxin/Antitoxin Kit 1022 Clostridium difficile 8 HIGH November 22, 1993
6654 K971182 61294 TechLab C. difficle TOX A/B TEST (spectrophotometric) 1022 Clostridium difficile 8 HIGH August 8, 1997
6655 K971182 61293 TechLab C. difficle TOX A/B TEST (visual) 1022 Clostridium difficile 8 HIGH August 8, 1997
6656 K935296 61147 TechLab Clostridium difficile TOX-B Test 1022 Clostridium difficile 8 HIGH September 15, 1994
6659 4424 All Manual Tilt-Tube Coagulation Procedures 1044 Coagulation Factors 4 HIGH July 26, 1993
6660 K904297 4728 American Bioproducts ST4 BIO 1044 Coagulation Factors 4 HIGH June 20, 1997
6661 K961579 4677 American Bioproducts STA Compact Analyzer 1044 Coagulation Factors 4 HIGH November 1, 1996
6662 K983460 4875 American Bioproducts STA-R Analyzer 1044 Coagulation Factors 4 HIGH October 25, 1999
6663 4145 American Scientific Fibrometer 1044 Coagulation Factors 4 HIGH July 26, 1993
6664 7080 Becton Dickinson BBL Fibrometer 1044 Coagulation Factors 4 HIGH July 26, 1993
6665 K955278 7824 Behring Coagulation Timer (BCT) 1044 Coagulation Factors 4 HIGH November 15, 1996
6666 K926551 7516 Behring Fibrintimer A 1044 Coagulation Factors 4 HIGH April 28, 1995
6667 K943153 7597 Bio/Data MCA 310 1044 Coagulation Factors 4 HIGH March 31, 1995
6668 7193 Bio/Data PAP-4C 1044 Coagulation Factors 4 HIGH July 26, 1993
6669 7217 Biopool Spectrolyse Factor VIII:C 1044 Coagulation Factors 4 HIGH July 26, 1993
6670 K981038 8143 Boehringer Mannheim Hitachi 704 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6671 K981038 8144 Boehringer Mannheim Hitachi 717 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6672 K981038 10457 Chromogenix Coamatic Factor VIII (manual) 1044 Coagulation Factors 4 HIGH December 8, 1998
6673 K970431 13608 Dade Behring Coagulation System (BCS) 1044 Coagulation Factors 4 HIGH January 26, 2000
6674 K934606 13297 Diagnostica Stago Deficient II Factor Assay (manual) 1044 Coagulation Factors 4 HIGH June 10, 1994
6675 K934605 13296 Diagnostica Stago Deficient V Factor Assay (manual) 1044 Coagulation Factors 4 HIGH June 10, 1994
6676 K933440 13305 Diagnostica Stago Deficient VII Factor Assay (manual) 1044 Coagulation Factors 4 HIGH September 30, 1994
6677 K933441 13306 Diagnostica Stago Deficient X Factor Assay (manual) 1044 Coagulation Factors 4 HIGH September 30, 1994
6678 K933444 13307 Diagnostica Stago Deficient XI Factor Assay (manual) 1044 Coagulation Factors 4 HIGH September 30, 1994
6679 K933438 13304 Diagnostica Stago Deficient XII Factor Assay (manual) 1044 Coagulation Factors 4 HIGH September 30, 1994
6680 13218 Diagnostica Stago ST4 1044 Coagulation Factors 4 HIGH July 26, 1993
6681 13146 Diagnostica Stago Stachrom VIII:C 1044 Coagulation Factors 4 HIGH July 26, 1993
6682 22138 General Diagnostics Coag-A-Mate 2001 1044 Coagulation Factors 4 HIGH July 26, 1993
6683 22137 General Diagnostics Coag-A-Mate Dual Channel 1044 Coagulation Factors 4 HIGH July 26, 1993
6684 22057 General Diagnostics Coag-A-Mate X2 1044 Coagulation Factors 4 HIGH July 26, 1993
6685 25002 Helena Laboratories Cascade 480 1044 Coagulation Factors 4 HIGH July 26, 1993
6686 K952668 25239 Helena Laboratories Chrom Z-Factor VIII:C (manual) 1044 Coagulation Factors 4 HIGH February 16, 1996
6687 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 1044 Coagulation Factors 4 HIGH July 26, 1993
6688 K952668 25029 Helena Laboratories PACKS-4 1044 Coagulation Factors 4 HIGH February 16, 1996
6689 K961908 25267 Helena Laboratories THOR 1044 Coagulation Factors 4 HIGH April 18, 1997
6690 K930235 28093 ITC Factor VI 1044 Coagulation Factors 4 HIGH November 22, 1993
6691 K930235 28296 ITC Factor VI Premier 1044 Coagulation Factors 4 HIGH November 22, 1993
6692 K930235 28094 ITC HEMOCHRON 400 1044 Coagulation Factors 4 HIGH November 22, 1993
6693 K930235 28095 ITC HEMOCHRON 401 1044 Coagulation Factors 4 HIGH November 22, 1993
6694 K930235 28096 ITC HEMOCHRON 800 1044 Coagulation Factors 4 HIGH November 22, 1993
6695 K930235 28298 ITC HEMOCHRON 8000 1044 Coagulation Factors 4 HIGH November 22, 1993
6696 K930235 28097 ITC HEMOCHRON 801 1044 Coagulation Factors 4 HIGH November 22, 1993
6697 28074 Instrumentation Laboratory IL ACL 1000 1044 Coagulation Factors 4 HIGH July 26, 1993
6698 28075 Instrumentation Laboratory IL ACL 200 1044 Coagulation Factors 4 HIGH July 26, 1993
6699 K981038 28541 Instrumentation Laboratory IL ACL 200 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6700 28076 Instrumentation Laboratory IL ACL 2000 1044 Coagulation Factors 4 HIGH July 26, 1993
6701 28077 Instrumentation Laboratory IL ACL 300 1044 Coagulation Factors 4 HIGH July 26, 1993
6702 K981038 28542 Instrumentation Laboratory IL ACL 300 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6703 28197 Instrumentation Laboratory IL ACL 300 Plus 1044 Coagulation Factors 4 HIGH July 26, 1993
6704 28078 Instrumentation Laboratory IL ACL 3000 1044 Coagulation Factors 4 HIGH July 26, 1993
6705 28079 Instrumentation Laboratory IL ACL 3000 Plus 1044 Coagulation Factors 4 HIGH July 26, 1993
6706 K961991 28454 Instrumentation Laboratory IL ACL 6000 1044 Coagulation Factors 4 HIGH September 13, 1996
6707 K961991 28487 Instrumentation Laboratory IL ACL 7000 1044 Coagulation Factors 4 HIGH September 19, 1997
6708 28080 Instrumentation Laboratory IL ACL 810 1044 Coagulation Factors 4 HIGH July 26, 1993
6709 37034 LAbor COA Data 2000 1044 Coagulation Factors 4 HIGH July 26, 1993
6710 37066 LAbor COA Data 3000 1044 Coagulation Factors 4 HIGH July 26, 1993
6711 37033 LAbor COA Screener 1044 Coagulation Factors 4 HIGH July 26, 1993
6712 37035 LAbor COA System 1044 Coagulation Factors 4 HIGH July 26, 1993
6713 37025 Lancer Coagulyzer Jr. III 1044 Coagulation Factors 4 HIGH July 26, 1993
6714 37013 Logos elvi 818 Digi Clot 1044 Coagulation Factors 4 HIGH July 26, 1993
6715 37014 Logos elvi 819 Multi Clot 1044 Coagulation Factors 4 HIGH July 26, 1993
6716 37015 Logos elvi 820 Digi Clot II 1044 Coagulation Factors 4 HIGH July 26, 1993
6717 40037 Medical Laboratory MLA Electra 1000 C 1044 Coagulation Factors 4 HIGH July 26, 1993
6718 K981038 40315 Medical Laboratory MLA Electra 1000C {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6719 K944227 40208 Medical Laboratory MLA Electra 1400C 1044 Coagulation Factors 4 HIGH April 7, 1995
6720 K931206 40167 Medical Laboratory MLA Electra 1600C 1044 Coagulation Factors 4 HIGH November 22, 1993
6721 K962664 40282 Medical Laboratory MLA Electra 1800C 1044 Coagulation Factors 4 HIGH December 5, 1997
6722 40039 Medical Laboratory MLA Electra 750 1044 Coagulation Factors 4 HIGH July 26, 1993
6723 40040 Medical Laboratory MLA Electra 800 1044 Coagulation Factors 4 HIGH July 26, 1993
6724 40122 Medical Laboratory MLA Electra 800 (with data management) 1044 Coagulation Factors 4 HIGH July 26, 1993
6725 40041 Medical Laboratory MLA Electra 900 1044 Coagulation Factors 4 HIGH July 26, 1993
6726 40042 Medical Laboratory MLA Electra 900C 1044 Coagulation Factors 4 HIGH July 26, 1993
6727 K981038 40314 Medical Laboratory MLA Electra 900C {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6728 K962857 46269 Organon Teknika Coag-A-Mate MTX 1044 Coagulation Factors 4 HIGH January 23, 1998
6729 46019 Organon Teknika Coag-A-Mate RA4 1044 Coagulation Factors 4 HIGH July 26, 1993
6730 46021 Organon Teknika Coag-A-Mate XC 1044 Coagulation Factors 4 HIGH July 26, 1993
6731 46022 Organon Teknika Coag-A-Mate XC Plus 1044 Coagulation Factors 4 HIGH July 26, 1993
6732 46023 Organon Teknika Coag-A-Mate XM 1044 Coagulation Factors 4 HIGH July 26, 1993
6733 K924453 46144 Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 1044 Coagulation Factors 4 HIGH November 22, 1993
6734 46111 Ortho KoaguLab M 1044 Coagulation Factors 4 HIGH July 26, 1993
6735 46076 Ortho Koagulab 40-A 1044 Coagulation Factors 4 HIGH July 26, 1993
6736 46122 Ortho Koagulab 60-S 1044 Coagulation Factors 4 HIGH July 26, 1993
6737 K992130 49231 Pacific Hemostasis ThromboScreen 400C 1044 Coagulation Factors 4 HIGH January 28, 2000
6738 K943225 49149 Pharmacia Hepar Chromogenix Coamatic Factor VIII 1044 Coagulation Factors 4 HIGH November 9, 1995
6739 K981038 55311 Roche Diagnostics Cobas Bio {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6740 K981038 55310 Roche Diagnostics Cobas FARA {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6741 K981038 55312 Roche Diagnostics Cobas Mira {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6742 K981038 55376 Roche Diagnostics Hitachi 704 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH May 7, 1999
6743 K981038 55411 Roche Diagnostics Hitachi 717 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH May 7, 1999
6744 58140 Sherwood Medical Coagulizer Jr. 1044 Coagulation Factors 4 HIGH July 26, 1993
6745 58049 Sigma Diagnostics AccuStasis 1000 1044 Coagulation Factors 4 HIGH July 26, 1993
6746 58050 Sigma Diagnostics AccuStasis 2000 1044 Coagulation Factors 4 HIGH July 26, 1993
6747 K955720 58413 Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) 1044 Coagulation Factors 4 HIGH September 27, 1996
6748 K955720 58414 Sigma Diagnostics Amelung AMAX CS-190 (manual dilution) 1044 Coagulation Factors 4 HIGH September 27, 1996
6749 K972260 58517 Sigma Diagnostics Amelung CS-400 (auto dilution) 1044 Coagulation Factors 4 HIGH June 19, 1998
6750 K972260 58516 Sigma Diagnostics Amelung CS-400 (manual dilution) 1044 Coagulation Factors 4 HIGH June 19, 1998
6751 K955735 58412 Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer 1044 Coagulation Factors 4 HIGH August 30, 1996
6752 K931149 58604 Sysmex CA-1000 1044 Coagulation Factors 4 HIGH January 27, 2000
6753 K933886 58605 Sysmex CA-5000 1044 Coagulation Factors 4 HIGH January 27, 2000
6754 K964139 58606 Sysmex CA-6000 1044 Coagulation Factors 4 HIGH January 27, 2000
6755 61065 TECO Diagnostics Coatron F2 1044 Coagulation Factors 4 HIGH July 26, 1993
6756 61047 TECO Diagnostics Coatron II 1044 Coagulation Factors 4 HIGH July 26, 1993
6757 61048 TECO Diagnostics Coatron Jr 1044 Coagulation Factors 4 HIGH July 26, 1993
6758 K931149 61132 TOA Medical Electronics CA-1000 1044 Coagulation Factors 4 HIGH June 10, 1994
6759 K933886 61135 TOA Medical Electronics CA-5000 1044 Coagulation Factors 4 HIGH June 10, 1994
6760 K981038 61378 Technicon RA 1000 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6761 K981038 61380 Technicon RA 2000 {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6762 K981038 61379 Technicon RA XT {Chromogenix Coamatic Factor VIII} 1044 Coagulation Factors 4 HIGH December 8, 1998
6763 K933010 67075 Vitek HEMOLAB 1044 Coagulation Factors 4 HIGH September 30, 1994
6764 K954437 25257 Haemoscope Thromboelastograph 3000S (TEG 3000S) 1128 Coagulation Index, Modified Whole Blood 4 HIGH May 10, 1996
6766 K954437 25257 Haemoscope Thromboelastograph 3000S (TEG 3000S) 1129 Coagulation Index, Modified/Recalcified PRP/PPP 4 HIGH May 10, 1996
6783 4275 Ames OPTIMATE 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6790 K941310 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6794 K941310 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6799 K941310 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6804 K941310 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH April 10, 1998
6815 K941310 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6819 K941310 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6823 K941310 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6840 13030 Diagnostic Products Corp. Coat-A-Count 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6865 28175 Immunotech Microzyme EIA (spectrophotometric) 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6870 28183 Instrumentation Laboratory Multistat III 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6871 28184 Instrumentation Laboratory Multistat III Plus 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6884 K945207 40232 Meco Industries MECTEST Cocaine Radioimmunoassay 1023 Cocaine Metabolites 7 HIGH October 27, 1995
6888 K941310 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
6934 K941310 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH May 7, 1999
6936 K941310 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH May 7, 1999
6942 K941310 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH May 7, 1999
6945 K941310 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH May 7, 1999
6959 K973651 58502 STC Technologies Cocaine Metabolite Micro-Plate EIA {EpiScreen Oral Fluid Specimens} 1023 Cocaine Metabolites 7 HIGH April 24, 1998
6961 58182 Serex CoMA Cocaine Metabolite Assay 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6962 58105 Sigma Diagnostics SIA Cocaine Metabolites 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6972 58188 Syva Emit st Drug Detection System 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6973 58190 Syva Qstat/Qst System 1023 Cocaine Metabolites 7 HIGH July 26, 1993
6980 K930985 64026 USDT Flow Immunoassay System 1023 Cocaine Metabolites 7 HIGH November 22, 1993
6981 K973156 64041 United Biotech UBI MAGIWEL ELISA for Cocaine Metabolites 1023 Cocaine Metabolites 7 HIGH April 10, 1998
6987 28028 Immuno-Mycologics ID-Cocci Antibody System 1024 Coccidioides Antibodies 3 HIGH July 26, 1993
6989 40101 Meridian Diagnostics Coccidioides Immunodiffusion System 1024 Coccidioides Antibodies 3 HIGH July 26, 1993
6991 40121 Meridian Diagnostics Premier Coccidioides EIA 1024 Coccidioides Antibodies 3 HIGH July 26, 1993
6992 22134 Gen-Probe AccuProbe - C. immitis (including culture) 1025 Coccidioides immitis 12 HIGH July 26, 1993
6993 28198 Immuno-Mycologics Exo-Antigen Test Kit (including culture) 1025 Coccidioides immitis 12 HIGH July 26, 1993
6997 K952320 40251 Metra Biosystems PYRILINKS-D 1127 Collagen Type I Crosslink, Deoxypyridinoline (Dpd) 6 HIGH May 3, 1996
6999 K945946 46193 Ostex International Osteomark 1125 Collagen Type I Crosslink, N-telopeptides (NTx) 6 HIGH May 26, 1995
7001 K952506 40250 Metra Biosystems PYRILINKS 1126 Collagen Type I Crosslink, pyridinium (Pyd, Dpd) 6 HIGH May 3, 1996
7002 K952026 40252 Metra Biosystems PYRILINKS Polyclonal 1126 Collagen Type I Crosslink, pyridinium (Pyd, Dpd) 6 HIGH May 3, 1996
7003 K960171 13416 Diagnostic Systems DSL 10-1700 ACTIVE CrossLaps ELISA 1131 Collagen Type I, C-telopeptides 6 HIGH May 10, 1996
7004 K972788 46313 Osteometer Biotech A/S Crosslaps ELISA 1131 Collagen Type I, C-telopeptides 6 HIGH June 4, 1999
7006 34010 Kent Radial Immunodiffusion Test 1027 Complement C1 3 HIGH July 26, 1993
7008 34010 Kent Radial Immunodiffusion Test 1026 Complement C1 inhibitor 3 HIGH July 26, 1993
7009 52003 Quidel C1-Inhibitor EIA 1026 Complement C1 inhibitor 3 HIGH July 26, 1993
7011 61080 The Binding Site Human C1 Inactivator RID 1026 Complement C1 inhibitor 3 HIGH July 26, 1993
7012 61073 The Binding Site Human Complement C1q NL RID 1064 Complement C1q 3 HIGH July 26, 1993
7019 7383 Beckman Auto ICS 1029 Complement C3 3 HIGH July 26, 1993
7020 7381 Beckman ICS 1029 Complement C3 3 HIGH July 26, 1993
7021 7382 Beckman ICS II 1029 Complement C3 3 HIGH July 26, 1993
7033 7119 Behring Nor-partigen Kit 1029 Complement C3 3 HIGH July 26, 1993
7035 7328 BioWhittaker FIAX System 1029 Complement C3 3 HIGH July 26, 1993
7048 25005 Helena Laboratories Quiplate System for RID 1029 Complement C3 3 HIGH July 26, 1993
7049 25024 Hycor Accuplate 1029 Complement C3 3 HIGH July 26, 1993
7058 28183 Instrumentation Laboratory Multistat III 1029 Complement C3 3 HIGH July 26, 1993
7059 28184 Instrumentation Laboratory Multistat III Plus 1029 Complement C3 3 HIGH July 26, 1993
7060 34001 Kallestad Endoplate RID 1029 Complement C3 3 HIGH July 26, 1993
7061 34010 Kent Radial Immunodiffusion Test 1029 Complement C3 3 HIGH July 26, 1993
7083 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 1029 Complement C3 3 HIGH July 26, 1993
7115 61072 The Binding Site Human Complement C3 & C4 RID 1029 Complement C3 3 HIGH July 26, 1993
7124 7383 Beckman Auto ICS 1030 Complement C4 3 HIGH July 26, 1993
7125 7381 Beckman ICS 1030 Complement C4 3 HIGH July 26, 1993
7126 7382 Beckman ICS II 1030 Complement C4 3 HIGH July 26, 1993
7136 7119 Behring Nor-partigen Kit 1030 Complement C4 3 HIGH July 26, 1993
7138 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1030 Complement C4 3 HIGH July 26, 1993
7139 7328 BioWhittaker FIAX System 1030 Complement C4 3 HIGH July 26, 1993
7151 25005 Helena Laboratories Quiplate System for RID 1030 Complement C4 3 HIGH July 26, 1993
7152 25024 Hycor Accuplate 1030 Complement C4 3 HIGH July 26, 1993
7160 28183 Instrumentation Laboratory Multistat III 1030 Complement C4 3 HIGH July 26, 1993
7161 28184 Instrumentation Laboratory Multistat III Plus 1030 Complement C4 3 HIGH July 26, 1993
7162 34001 Kallestad Endoplate RID 1030 Complement C4 3 HIGH July 26, 1993
7163 34003 Kallestad Quantiplate RID 1030 Complement C4 3 HIGH July 26, 1993
7164 34010 Kent Radial Immunodiffusion Test 1030 Complement C4 3 HIGH July 26, 1993
7185 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 1030 Complement C4 3 HIGH July 26, 1993
7217 61072 The Binding Site Human Complement C3 & C4 RID 1030 Complement C4 3 HIGH July 26, 1993
7220 34010 Kent Radial Immunodiffusion Test 1031 Complement C5 3 HIGH July 26, 1993
7221 K942326 61206 The Binding Site Human Complement C5 RID 1031 Complement C5 3 HIGH September 29, 1995
7226 K951639 28404 Incstar Complement Activation EIA Test System (CAE) 1046 Complement, Total 3 HIGH October 20, 1995
7228 34003 Kallestad Quantiplate RID 1046 Complement, Total 3 HIGH July 26, 1993
7231 K974111 52102 Quidel CH50 Eq EIA 1046 Complement, Total 3 HIGH October 16, 1998
7238 58051 Sigma Diagnostics Test Kit 1046 Complement, Total 3 HIGH July 26, 1993
7239 K992488 61450 The Binding Site Total Haemolytic Complement Kit 1046 Complement, Total 3 HIGH October 25, 1999
7243 4148 Amersham Amerlite 1032 Cortisol 6 HIGH July 26, 1993
7248 7087 Becton Dickinson Corti-Cote 1032 Cortisol 6 HIGH July 26, 1993
7249 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1032 Cortisol 6 HIGH July 26, 1993
7250 7141 Bio-Rad Quantimune 1032 Cortisol 6 HIGH July 26, 1993
7251 7275 Biomerica EIA Test Kit 1032 Cortisol 6 HIGH July 26, 1993
7265 10051 Ciba Corning Magic (MGC) 1032 Cortisol 6 HIGH July 26, 1993
7268 10060 Clinical Assays GammaCoat 1032 Cortisol 6 HIGH July 26, 1993
7272 13030 Diagnostic Products Corp. Coat-A-Count 1032 Cortisol 6 HIGH July 26, 1993
7273 13031 Diagnostic Products Corp. Double Antibody 1032 Cortisol 6 HIGH July 26, 1993
7274 13111 Diagnostic Products Corp. Milenia 1032 Cortisol 6 HIGH July 26, 1993
7275 13176 Diagnostic Systems Active Cortisol RIA Kit 1032 Cortisol 6 HIGH July 26, 1993
7276 13183 Diagnostic Systems Cortisol RIA Kit 1032 Cortisol 6 HIGH July 26, 1993
7278 28172 Immunotech ENDAB EIA Kit 1032 Cortisol 6 HIGH July 26, 1993
7279 34031 Kallestad Quanticoat 1032 Cortisol 6 HIGH July 26, 1993
7280 40085 Micromedic Systems CONCEPT 4 1032 Cortisol 6 HIGH July 26, 1993
7281 40111 Micromedic Systems Concept 4 Plus 1032 Cortisol 6 HIGH July 26, 1993
7283 43082 Nichols Institute Chemiluminescence Cortisol Assay 1032 Cortisol 6 HIGH September 1, 1994
7284 46007 Organon NML IRMA Test Kit 1032 Cortisol 6 HIGH July 26, 1993
7296 58010 Sanofi/Kallestad Quanticoat 1032 Cortisol 6 HIGH July 26, 1993
7299 58091 Serono Baker Serozyme 1032 Cortisol 6 HIGH July 26, 1993
7301 58251 Serono Diagnostics Serozyme 1032 Cortisol 6 HIGH July 26, 1993
7313 K931177 16048 elias usa Synelisa Cortisol 1032 Cortisol 6 HIGH May 20, 1994
7322 13176 Diagnostic Systems Active Cortisol RIA Kit 1033 Cortisol, Urine (direct procedure) 6 HIGH July 26, 1993
7324 4071 Abbott TDX 1095 Cortisol, Urine (extraction procedure) 6 HIGH September 1, 1994
7325 4072 Abbott TDX FLx 1095 Cortisol, Urine (extraction procedure) 6 HIGH September 1, 1994
7326 K940221 7914 Beckman ACCESS Immunoassay System 1095 Cortisol, Urine (extraction procedure) 6 HIGH May 16, 1997
7327 K945367 10375 Chiron Diagnostics ACS 180 1095 Cortisol, Urine (extraction procedure) 6 HIGH November 15, 1996
7328 K940810 10376 Chiron Diagnostics ACS 180 Plus 1095 Cortisol, Urine (extraction procedure) 6 HIGH November 15, 1996
7329 K971418 10440 Chiron Diagnostics ACS:Centaur 1095 Cortisol, Urine (extraction procedure) 6 HIGH April 24, 1998
7330 K940810 10336 Ciba Corning ACS 180 Plus 1095 Cortisol, Urine (extraction procedure) 6 HIGH October 25, 1996
7331 13175 Diagnostic Systems Active Cortisol EIA Kit 1095 Cortisol, Urine (extraction procedure) 6 HIGH July 26, 1993
7332 K984520 43122 Nichols Institute Advantage Chemiluminescence System 1095 Cortisol, Urine (extraction procedure) 6 HIGH November 1, 1999
7333 K983990 46279 Ortho-Clinical Diagnostics Vitros ECi 1095 Cortisol, Urine (extraction procedure) 6 HIGH January 22, 1999
7334 K940221 58257 Sanofi Pasteur Access Immunoassay System 1095 Cortisol, Urine (extraction procedure) 6 HIGH September 15, 1994
7335 K931031 67038 Vitek Systems Vidas 1095 Cortisol, Urine (extraction procedure) 6 HIGH November 22, 1993
7336 K931031 7806 bioMerieux Vitek VIDAS 1095 Cortisol, Urine (extraction procedure) 6 HIGH October 25, 1996
7341 K972481 8021 Boehringer Mannheim Hitachi 747 {STC Auto-Lyte} (manual curve) 1042 Cotinine 7 HIGH January 9, 1998
7343 K972481 55505 Roche Diagnostics Hitachi 747 {STC Auto-Lyte} (manual curve) 1042 Cotinine 7 HIGH May 7, 1999
7344 K974534 58518 STC Technologies Cotinine Micro-Plate EIA (qualitative) 1042 Cotinine 7 HIGH July 10, 1998
7345 K974534 58519 STC Technologies Cotinine Micro-Plate EIA (semi-quantitative) 1042 Cotinine 7 HIGH July 10, 1998
7346 K974234 58520 STC Technologies Cotinine Micro-Plate EIA {EpiScreen Oral Fluid Specimens} (qualitative) 1042 Cotinine 7 HIGH July 10, 1998
7347 K974234 58521 STC Technologies Cotinine Micro-Plate EIA {EpiScreen Oral Fluid Specimens} (semi-quantitative) 1042 Cotinine 7 HIGH July 10, 1998
7348 K913906 25131 Hillcrest Biologicals Q Fever (IgG) IFA Test 1067 Coxiella burnetti (Q Fever) Antibodies 3 HIGH November 22, 1993
7349 K922374 25130 Hillcrest Biologicals Q Fever (IgM) IFA Test 1067 Coxiella burnetti (Q Fever) Antibodies 3 HIGH November 22, 1993
7350 K936089 37073 Light Diagnostics MAb Coxsackie A24 Virus (including culture) 1098 Coxsackie A24 Virus 10 HIGH September 15, 1995
7351 K936073 37072 Light Diagnostics MAb Coxsackie A9 Virus (including culture) 1097 Coxsackie A9 Virus 10 HIGH September 15, 1995
7352 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1099 Coxsackie B1 Virus 10 HIGH September 15, 1995
7353 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1100 Coxsackie B2 Virus 10 HIGH September 15, 1995
7354 K936252 37075 Light Diagnostics MAb Coxsackie B2 Virus (including culture) 1100 Coxsackie B2 Virus 10 HIGH September 15, 1995
7355 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1101 Coxsackie B3 Virus 10 HIGH September 15, 1995
7356 K936251 37076 Light Diagnostics MAb Coxsackie B3 Virus (including culture) 1101 Coxsackie B3 Virus 10 HIGH September 15, 1995
7357 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1102 Coxsackie B4 Virus 10 HIGH September 15, 1995
7358 K936253 37077 Light Diagnostics MAb Coxsackie B4 Virus (including culture) 1102 Coxsackie B4 Virus 10 HIGH September 22, 1995
7359 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1103 Coxsackie B5 Virus 10 HIGH September 15, 1995
7360 K940472 37078 Light Diagnostics MAb Coxsackie B5 Virus (including culture) 1103 Coxsackie B5 Virus 10 HIGH September 15, 1995
7361 K940471 37087 Light Diagnostics MAb Coxsackie B Virus Blend (including culture) 1104 Coxsackie B6 Virus 10 HIGH September 15, 1995
7362 K936254 37079 Light Diagnostics MAb Coxsackie B6 Virus (including culture) 1104 Coxsackie B6 Virus 10 HIGH September 15, 1995
7366 4035 Abbott Bichromatic ABA 100 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7367 4267 Abbott Bichromatic ABA 50 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7379 4143 American Monitor KDA 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7380 4144 American Monitor Parallel 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7382 4275 Ames OPTIMATE 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7388 7378 Beckman Manual Spectrophotometric Test Procedure 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7428 13216 DMA Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7439 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7451 16010 Electronucleonics FLEXIGEM 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7457 K962247 25263 HiChem Creatine Kinase Reagent Kit (manual) 1034 Creatine Kinase (CK) 2 HIGH October 25, 1996
7458 K881327 25211 Horizon Creatine Kinase (manual) 1034 Creatine Kinase (CK) 2 HIGH April 28, 1995
7465 28183 Instrumentation Laboratory Multistat III 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7466 28184 Instrumentation Laboratory Multistat III Plus 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7485 K931326 34051 King Diagnostics Test Kit 1034 Creatine Kinase (CK) 2 HIGH November 22, 1993
7496 40126 Mallinckrodt Serometer 370 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7497 K952745 40220 MeDiTech Creatine Kinase (CK) (manual) 1034 Creatine Kinase (CK) 2 HIGH August 18, 1995
7498 40124 Medical Analysis Systems RefLab Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7499 40118 Meditech Diagnostic System Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7525 49064 Pointe Scientific 180 Chemistry Analyzer 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7526 K930660 49104 Pointe Scientific Manual Creatine Kinase Test 1034 Creatine Kinase (CK) 2 HIGH November 22, 1993
7528 K923511 55117 Randox Laboratories CK NAC-activated Test Kit 1034 Creatine Kinase (CK) 2 HIGH November 22, 1993
7529 55075 Reagents Applications RAICHEM Test Kit (manual) 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7555 58185 Seragen StatEase 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7556 58051 Sigma Diagnostics Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7557 58157 Stanbio Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7558 58229 Sterling Diagnostics Analyzer 2000 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7559 58230 Sterling Diagnostics Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7561 K930932 58260 Synermed Test Kit 1034 Creatine Kinase (CK) 2 HIGH November 22, 1993
7562 K864744 61408 TECO Diagnostics Creatine Kinase (CK) Reagent Set (manual) 1034 Creatine Kinase (CK) 2 HIGH March 26, 1999
7563 K882938 61377 TECO Diagnostics TC 84 1034 Creatine Kinase (CK) 2 HIGH November 19, 1998
7564 61044 TRACE Scientific Test Kit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7575 61014 Technicon SMA 12/60 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7576 61016 Technicon SMAC 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7577 61046 Technicon SMAC 3 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7579 70102 Wako Autokit 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
7582 7256 Biomerica RIA Test Kit 1047 Creatine Kinase BB Fraction (CKBB) 2 HIGH July 26, 1993
7583 13182 Diagnostic Systems CK-B Protein RIA Kit 1047 Creatine Kinase BB Fraction (CKBB) 2 HIGH July 26, 1993
7584 28164 International Immunoassay Labs ABURIA-CK RIA Kit 1047 Creatine Kinase BB Fraction (CKBB) 2 HIGH July 26, 1993
7585 7363 Beckman Paragon CK Isoenzyme Electrophoresis Kit 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7586 25088 Helena Laboratories CK Isoforms Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7587 25084 Helena Laboratories CPK Isoenzyme Electrophoresis 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7588 25070 Helena Laboratories CPK-US Isoenzyme Electrophoresis 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7589 25101 Helena Laboratories REP CK Isoenzyme Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7590 25100 Helena Laboratories REP CK/LD Isoenzyme Combo Method 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7591 K925801 25153 Helena Laboratories REP E-Z CK-30 Isoenzyme Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH November 22, 1993
7592 25093 Helena Laboratories Titan Gel CK Isoenzyme Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7593 25090 Helena Laboratories Titan Gel Iso-Dot CK (black) 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7594 25094 Helena Laboratories Titan Gel-PC CK Isoenzyme Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
7595 K992148 58597 Sebia HYDRASYS {Hydragel 7/15/30 ISO-CK} 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH January 26, 2000
7597 4035 Abbott Bichromatic ABA 100 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7637 K942958 10280 CHEMROY Creatine Kinase-MB (CK-MB) Reagent Set 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH December 9, 1994
7642 10055 Ciba Corning Magic Lite 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7648 13216 DMA Test Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7662 K942773 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH October 14, 1994
7663 13182 Diagnostic Systems CK-B Protein RIA Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7683 K930359 25140 Helena Laboratories Cardio REP CK Isoforms Procedure 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH November 22, 1993
7684 K915709 25203 Horizon Creatine Kinase MB (manual) 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH April 28, 1995
7686 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7687 25053 Hybritech Photon Immunoassay Analyzer 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7688 25022 Hybritech Tandem-E 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7695 28183 Instrumentation Laboratory Multistat III 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7696 28184 Instrumentation Laboratory Multistat III Plus 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7697 28164 International Immunoassay Labs ABURIA-CK RIA Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7698 28165 International Immunoassay Labs EMBRIA-CK IRMA Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7699 28168 International Immunoassay Labs IMACK-MB Test Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7700 28162 International Immunoassay Labs IMpres-MB 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7701 28163 International Immunoassay Labs IMpres-MB-X 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7702 28169 International Immunoassay Labs MicroMI-MB Test Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7703 28167 International Immunoassay Labs QuiCK-MB IRMA Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7750 K935463 49117 Pointe Scientific Creatine Kinase - MB (manual) 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH June 10, 1994
7757 K951223 55159 Randox Laboratories CK-MB NAC-activated Test Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH January 27, 2000
7758 55075 Reagents Applications RAICHEM Test Kit (manual) 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7782 58160 Seradyn CK-MB Immuno UV Determination 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7783 58051 Sigma Diagnostics Test Kit 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
7786 K915709 61409 TECO Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set (manual) 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH March 26, 1999
7797 7364 Beckman Paragon CK-MM Isoforms Electrophoresis Kit 1054 Creatine Kinase MM Fraction (CKMM) 2 HIGH July 26, 1993
7798 28170 International Immunoassay Labs CheCK-MM 1054 Creatine Kinase MM Fraction (CKMM) 2 HIGH July 26, 1993
7799 28161 International Immunoassay Labs ISOFOR-MM 1054 Creatine Kinase MM Fraction (CKMM) 2 HIGH July 26, 1993
7803 4035 Abbott Bichromatic ABA 100 1035 Creatinine 2 HIGH July 26, 1993
7804 4036 Abbott Bichromatic ABA 200 1035 Creatinine 2 HIGH July 26, 1993
7805 4267 Abbott Bichromatic ABA 50 1035 Creatinine 2 HIGH July 26, 1993
7816 4143 American Monitor KDA 1035 Creatinine 2 HIGH July 26, 1993
7817 4144 American Monitor Parallel 1035 Creatinine 2 HIGH July 26, 1993
7819 4275 Ames OPTIMATE 1035 Creatinine 2 HIGH July 26, 1993
7850 7254 Boehringer Mannheim Biodynamics Unimeter 250 1035 Creatinine 2 HIGH July 26, 1993
7851 7252 Boehringer Mannheim Biodynamics Unimeter 300 1035 Creatinine 2 HIGH July 26, 1993
7852 7253 Boehringer Mannheim Biodynamics Unimeter 330K 1035 Creatinine 2 HIGH July 26, 1993
7864 K950142 10295 Chimera CR Perfect Urine Creatinine (manual) 1035 Creatinine 2 HIGH June 2, 1995
7876 13216 DMA Test Kit 1035 Creatinine 2 HIGH July 26, 1993
7897 16010 Electronucleonics FLEXIGEM 1035 Creatinine 2 HIGH July 26, 1993
7904 28157 Instrumentation Laboratory IL 504 1035 Creatinine 2 HIGH July 26, 1993
7905 28158 Instrumentation Laboratory IL 508 1035 Creatinine 2 HIGH July 26, 1993
7914 28184 Instrumentation Laboratory Multistat III Plus 1035 Creatinine 2 HIGH July 26, 1993
7948 40126 Mallinckrodt Serometer 370 1035 Creatinine 2 HIGH July 26, 1993
7949 40124 Medical Analysis Systems RefLab Test Kit 1035 Creatinine 2 HIGH July 26, 1993
7950 40118 Meditech Diagnostic System Test Kit 1035 Creatinine 2 HIGH July 26, 1993
7977 49064 Pointe Scientific 180 Chemistry Analyzer 1035 Creatinine 2 HIGH July 26, 1993
7979 55075 Reagents Applications RAICHEM Test Kit (manual) 1035 Creatinine 2 HIGH July 26, 1993
8004 58185 Seragen StatEase 1035 Creatinine 2 HIGH July 26, 1993
8005 58051 Sigma Diagnostics Test Kit 1035 Creatinine 2 HIGH July 26, 1993
8006 58210 Stanbio Premiere 1035 Creatinine 2 HIGH July 26, 1993
8007 58157 Stanbio Test Kit 1035 Creatinine 2 HIGH July 26, 1993
8008 58229 Sterling Diagnostics Analyzer 2000 1035 Creatinine 2 HIGH July 26, 1993
8009 58230 Sterling Diagnostics Test Kit 1035 Creatinine 2 HIGH July 26, 1993
8012 K926511 58260 Synermed Test Kit 1035 Creatinine 2 HIGH November 22, 1993
8013 K880629 61410 TECO Diagnostics Creatinine Reagent Set (manual) 1035 Creatinine 2 HIGH March 26, 1999
8014 K882938 61377 TECO Diagnostics TC 84 1035 Creatinine 2 HIGH November 19, 1998
8015 61044 TRACE Scientific Test Kit 1035 Creatinine 2 HIGH July 26, 1993
8026 61014 Technicon SMA 12/60 1035 Creatinine 2 HIGH July 26, 1993
8027 61015 Technicon SMA 6/60 1035 Creatinine 2 HIGH July 26, 1993
8028 61016 Technicon SMAC 1035 Creatinine 2 HIGH July 26, 1993
8029 61045 Technicon SMAC 2 1035 Creatinine 2 HIGH July 26, 1993
8030 61046 Technicon SMAC 3 1035 Creatinine 2 HIGH July 26, 1993
8035 4326 Alexon-Trend ProSpecT Cryptosporidium Microtiter (direct Ag/spectrophotometric) 1109 Cryptosporidium 11 HIGH February 3, 1995
8037 K955157 4655 Alexon-Trend ProSpecT Giardia/Crypto. Microplate (direct Ag/spectrophotometric) 1109 Cryptosporidium 11 HIGH March 1, 1996
8038 K955157 4654 Alexon-Trend ProSpecT Giardia/Crypto. Microplate (direct Ag/visual) 1109 Cryptosporidium 11 HIGH March 1, 1996
8041 37018 LMD Laboratories Cryptosporidium Ag Detect. Microtiter (visual) 1109 Cryptosporidium 11 HIGH February 3, 1995
8042 40100 Meridian Diagnostics MERIFLUOR Cryptosporidium 1109 Cryptosporidium 11 HIGH February 3, 1995
8043 40095 Meridian Diagnostics MERIFLUOR Cryptosporidium/Giardia 1109 Cryptosporidium 11 HIGH February 3, 1995
8044 58184 Seradyn Color Vue - Cryptosporidium (direct Ag/spectrophotometric) 1109 Cryptosporidium 11 HIGH February 3, 1995
8045 58297 Seradyn Color Vue - Cryptosporidium (direct Ag/visual) 1109 Cryptosporidium 11 HIGH February 3, 1995
8046 K955852 61262 TechLab Crypto-Cel IF Test 1109 Cryptosporidium 11 HIGH November 8, 1996
8047 K955897 61263 TechLab Crypto/Giardia-Cel IF Test 1109 Cryptosporidium 11 HIGH November 8, 1996
8048 K980354 61356 TechLab Cryptosporidium TEST (direct Ag/spectrophotometric) 1109 Cryptosporidium 11 HIGH June 12, 1998
8049 K980354 61357 TechLab Cryptosporidium TEST (direct Ag/visual) 1109 Cryptosporidium 11 HIGH June 12, 1998
8050 K955755 61252 Trend Scientific Crypto. parvum Direct Detection System (spectrophotometric) 1109 Cryptosporidium 11 HIGH July 26, 1996
8051 K955755 61251 Trend Scientific Crypto. parvum Direct Detection System (visual) 1109 Cryptosporidium 11 HIGH July 26, 1996
8052 13110 Diagnostic Products Corp. Liquid Phase 1043 Cyclic AMP 6 HIGH July 26, 1993
8053 28210 Incstar cAMP 1043 Cyclic AMP 6 HIGH July 26, 1993
8056 7279 Bio-Rad HPLC 1037 Cyclosporine 7 HIGH July 26, 1993
8057 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 1107 Cystathionine 2 HIGH November 10, 1994
8058 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 1106 Cystine 2 HIGH November 10, 1994
8060 7025 Baxter Bartels CMV Immed. Early Ag IFA (including cell culture) 1038 Cytomegalovirus 10 HIGH July 26, 1993
8061 7355 Baxter Bartels Direct CMV Kit (direct Ag) 1038 Cytomegalovirus 10 HIGH July 26, 1993
8062 7357 Baxter Bartels Direct CMV Kit (including cell culture) 1038 Cytomegalovirus 10 HIGH July 26, 1993
8063 K951550 7661 Biotest Diagnostics CMV Brite (direct Ag) 1038 Cytomegalovirus 10 HIGH February 2, 1996
8064 K934798 13298 Diagnostic Products PathoDx Cytomegalovirus (including cell culture) 1038 Cytomegalovirus 10 HIGH June 10, 1994
8065 K974901 13543 Digene Hybrid Capture CMV DNA Assay 1038 Cytomegalovirus 10 HIGH January 11, 1999
8066 K951851 13386 Du Pont Alliance CMV-Direct EA IFA (including cell culture) 1038 Cytomegalovirus 10 HIGH August 9, 1996
8067 K912592 22105 Gull Laboratories CMV-EA Test (including cell culture) 1038 Cytomegalovirus 10 HIGH July 26, 1993
8068 K982311 28568 INTRACEL Bartels CINAKIT CMV Antigenemia 1038 Cytomegalovirus 10 HIGH November 19, 1999
8069 K904036 28585 INTRACEL Bartels CMV Immed. Early Ag IFA (including cell culture) 1038 Cytomegalovirus 10 HIGH January 18, 2000
8070 K894002 28590 INTRACEL Bartels Direct CMV DFA Kit (direct Ag) 1038 Cytomegalovirus 10 HIGH January 18, 2000
8071 K894002 28591 INTRACEL Bartels Direct CMV DFA Kit (including cell culture) 1038 Cytomegalovirus 10 HIGH January 18, 2000
8072 28200 Incstar CMV-vue 1038 Cytomegalovirus 10 HIGH July 26, 1993
8073 K951821 37100 Light Diagnostics CMV Direct IFA (including cell culture) 1038 Cytomegalovirus 10 HIGH June 14, 1996
8074 K935809 37089 Light Diagnostics Cytomegalovirus Indirect Immunofluorescence Kit 1038 Cytomegalovirus 10 HIGH September 15, 1994
8075 K942171 43092 NeoGenex CMV Early Antigen Test (including cell culture) 1038 Cytomegalovirus 10 HIGH September 15, 1994
8076 K983762 46332 Organon Teknika NucliSens CMV pp67 1038 Cytomegalovirus 10 HIGH January 18, 2000
8077 58083 Syva MicroTrak CMV Culture ID Kit (including cell culture) 1038 Cytomegalovirus 10 HIGH July 26, 1993
8080 4039 Abbott CMV Total Ab EIA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8081 4524 Abbott CMV-M EIA 1039 Cytomegalovirus Antibodies 3 HIGH September 1, 1994
8082 4334 Abbott COMMANDER System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8084 4158 Amico Amizyme CMV Ab Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8085 4341 Analytab ACCU-LYZA CMV IgG ELISA Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8086 4340 Analytab ACCU-LYZA CMV IgM ELISA Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8087 K922582 7502 Baxter Bartels Cytomegalovirus IgG PRIMA System EIA 1039 Cytomegalovirus Antibodies 3 HIGH November 22, 1993
8088 K922580 7501 Baxter Bartels Cytomegalovirus IgM PRIMA System EIA 1039 Cytomegalovirus Antibodies 3 HIGH November 22, 1993
8089 7296 Baxter Bartels PRIMA Cytomegalovirus IgG EIA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8090 7297 Baxter Bartels PRIMA Cytomegalovirus IgM EIA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8094 7313 Bio-Medical Virotech ELISA Antibody Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8095 7321 BioWhittaker CMV CAP-M 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8096 7322 BioWhittaker CMV STAT 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8097 7323 BioWhittaker CMV STAT M 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8098 7324 BioWhittaker CYTOMEGELISA II 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8099 7328 BioWhittaker FIAX System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8101 7154 Bion CMV-G Antibody Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8102 K896295 10306 Centocor CAPTIA CMV-M 1039 Cytomegalovirus Antibodies 3 HIGH May 12, 1995
8103 K950010 10300 Centocor CAPTIA CMV-TA EIA 1039 Cytomegalovirus Antibodies 3 HIGH May 12, 1995
8105 13339 DAKO IDEIA CMV-M 1039 Cytomegalovirus Antibodies 3 HIGH March 3, 1995
8106 K915479 13338 DAKO IDEIA CMV-TA 1039 Cytomegalovirus Antibodies 3 HIGH March 3, 1995
8109 13224 Diamedix CMV IgG Microassay 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8110 13225 Diamedix CMV IgM Microassay 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8111 K981163 13514 Diamedix Immunosimplicity (Is)-CMV IgG (manual/qualitative) 1039 Cytomegalovirus Antibodies 3 HIGH September 25, 1998
8112 K981163 13515 Diamedix Immunosimplicity (Is)-CMV IgG (manual/semi-quantitative) 1039 Cytomegalovirus Antibodies 3 HIGH September 25, 1998
8115 22218 GenBio Cytomegalovirus IgG IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH August 1, 1997
8116 22219 GenBio Cytomegalovirus IgM IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH August 1, 1997
8122 22151 General Biometrics Cytomegalovirus IgM IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8126 K853137 22073 Gull Laboratories CMV IFA Antibodies Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8127 K915892 22074 Gull Laboratories CMV IgG ELISA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8128 K903807 22075 Gull Laboratories CMV IgM ELISA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8129 K831711 22076 Gull Laboratories CMV IgM IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8130 K944438 25181 Hemagen CMV IgG ELISA (qualitative) 1039 Cytomegalovirus Antibodies 3 HIGH February 28, 1997
8131 K944438 25177 Hemagen CMV IgG ELISA (semi-quantitative) 1039 Cytomegalovirus Antibodies 3 HIGH February 28, 1997
8132 K971335 28509 INOVA Diagnostics QUANTA Lite CMV IgG ELISA 1039 Cytomegalovirus Antibodies 3 HIGH December 19, 1997
8133 28137 Immuno Concepts CMV IgG Ab Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8134 28141 Immuno Concepts CMV IgM Ab Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8135 K955361 28460 Incstar CMV IgG ELISA 1039 Cytomegalovirus Antibodies 3 HIGH November 8, 1996
8136 K960434 28462 Incstar CMV IgM Capture ELISA 1039 Cytomegalovirus Antibodies 3 HIGH November 8, 1996
8137 28219 Incstar Clin-ELISA Cytomegalovirus IgG 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8138 28220 Incstar Clin-ELISA Cytomegalovirus IgM 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8139 28042 Incstar Fluoro-Kit 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8141 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8146 49019 Pharmacia CMV IgG ELISA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8147 K954191 52046 Quest International SeraQuest CMV IgG (manual/qualitative) 1039 Cytomegalovirus Antibodies 3 HIGH December 13, 1996
8148 K954191 52030 Quest International SeraQuest CMV IgG (manual/semi-quantitative) 1039 Cytomegalovirus Antibodies 3 HIGH March 1, 1996
8150 K954191 52047 Quest International SeraQuest CMV IgG {Hyperion HyPrep Plus} (manual calculations) 1039 Cytomegalovirus Antibodies 3 HIGH December 13, 1996
8151 K982485 52107 Quest International SeraQuest CMV IgM (manual/qualitative) 1039 Cytomegalovirus Antibodies 3 HIGH March 12, 1999
8152 K982485 52108 Quest International SeraQuest CMV IgM (manual/semi-quantitative) 1039 Cytomegalovirus Antibodies 3 HIGH March 12, 1999
8153 K982485 52110 Quest International SeraQuest CMV IgM {Hyperion HyPrep Plus} (manual calculations) 1039 Cytomegalovirus Antibodies 3 HIGH March 12, 1999
8156 58091 Serono Baker Serozyme 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8157 58251 Serono Diagnostics Serozyme 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8163 58214 Sigma Diagnostics SIA CMV IgG 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8164 58213 Sigma Diagnostics SIA CMV IgM 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8165 58147 Syva MicroTrak CMV-M EIA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8166 58148 Syva MicroTrak CMV-TA EIA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8168 67019 Virgo Cytomegalovirus IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8170 79005 Zeus Scientific CMV IgG ELISA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8171 79004 Zeus Scientific CMV IgG IFA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8172 79029 Zeus Scientific CMV IgM ELISA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8173 79037 Zeus Scientific CMV IgM IFA 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
8175 4115 All Immunohematology Absorption/Elution Procedures-Ag confirmation 1301 D(Rho) Type 5 HIGH July 26, 1993
8187 13113 Dynatech MicroBank System 1301 D(Rho) Type 5 HIGH July 26, 1993
8194 28087 IBG Inverness Blood Grouping System 1301 D(Rho) Type 5 HIGH July 26, 1993
8199 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 1301 D(Rho) Type 5 HIGH July 26, 1993
8204 K945642 4580 AGEN Dimertest Gold EIA 1320 D-dimer 4 HIGH November 3, 1995
8209 4425 American Diagnostica Dimertest StripWell EIA Kit 1320 D-dimer 4 HIGH July 26, 1993
8216 13135 Diagnostica Stago ASSERACHROM D-Di 1320 D-dimer 4 HIGH July 26, 1993
8226 13030 Diagnostic Products Corp. Coat-A-Count 1309 Dehydroepiandrosterone (DHEA) 6 HIGH July 26, 1993
8227 K955114 13410 Diagnostic Systems DSL 10-9000 ACTIVE DHEA EIA 1309 Dehydroepiandrosterone (DHEA) 6 HIGH March 1, 1996
8228 K935014 13309 Diagnostic Systems DSL-9000 ACTIVE DHEA RIA Kit 1309 Dehydroepiandrosterone (DHEA) 6 HIGH September 15, 1994
8229 43079 Nichols Institute Chemiluminescence DHEA Assay 1309 Dehydroepiandrosterone (DHEA) 6 HIGH September 1, 1994
8231 7256 Biomerica RIA Test Kit 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH July 26, 1993
8234 13030 Diagnostic Products Corp. Coat-A-Count 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH July 26, 1993
8235 13177 Diagnostic Systems Active DHEA-Sulfate EIA Kit 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH July 26, 1993
8236 13202 Diagnostic Systems Active DHEA-Sulfate RIA Kit 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH July 26, 1993
8237 13191 Diagnostic Systems DHEA-Sulfate RIA Kit 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH July 26, 1993
8238 K962895 13433 Diagnostic Systems DSL-C2700 DHEA-S-7 RIA 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH October 4, 1996
8239 K973897 34102 KMI Diagnostics DHEA-S ELISA 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH March 26, 1999
8241 K931601 43083 Nichols Institute Chemiluminescence DHEA-S Assay 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH November 22, 1993
8242 K935469 16062 elias usa Synelisa DHEA Sulfate EIA Kit 1310 Dehydroepiandrosterone Sulfate (DHEA-SO4) 6 HIGH September 30, 1994
8243 7499 BioScan Video Phase Contrast Microscope 1317 Dental plaque 8 HIGH September 1, 1994
8261 46096 Orion Diagnostica Oricult-DTM (microculture method) 1302 Dermatophytes 12 HIGH July 26, 1993
8287 13030 Diagnostic Products Corp. Coat-A-Count 1303 Digitoxin 7 HIGH July 26, 1993
8293 28172 Immunotech ENDAB EIA Kit 1303 Digitoxin 7 HIGH July 26, 1993
8309 K922353 4857 Alfa Scientific Designs Digoxin Coated Tube RIA 1304 Digoxin 7 HIGH July 23, 1999
8310 4148 Amersham Amerlite 1304 Digoxin 7 HIGH July 26, 1993
8342 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1304 Digoxin 7 HIGH July 26, 1993
8382 10060 Clinical Assays GammaCoat 1304 Digoxin 7 HIGH July 26, 1993
8396 13030 Diagnostic Products Corp. Coat-A-Count 1304 Digoxin 7 HIGH July 26, 1993
8397 K924504 13287 Diatron FAST Test System 1304 Digoxin 7 HIGH January 21, 1994
8412 28172 Immunotech ENDAB EIA Kit 1304 Digoxin 7 HIGH July 26, 1993
8413 28173 Immunotech EZ-BEAD EIA Kit 1304 Digoxin 7 HIGH July 26, 1993
8427 K880823 31016 Johnson & Johnson CDL Amerlite Analyzer 1304 Digoxin 7 HIGH August 18, 1995
8430 34031 Kallestad Quanticoat 1304 Digoxin 7 HIGH July 26, 1993
8432 40085 Micromedic Systems CONCEPT 4 1304 Digoxin 7 HIGH July 26, 1993
8433 40111 Micromedic Systems Concept 4 Plus 1304 Digoxin 7 HIGH July 26, 1993
8441 46100 Organon NML Digi-Tab RIA 1304 Digoxin 7 HIGH July 26, 1993
8446 49064 Pointe Scientific 180 Chemistry Analyzer 1304 Digoxin 7 HIGH July 26, 1993
8488 58010 Sanofi/Kallestad Quanticoat 1304 Digoxin 7 HIGH July 26, 1993
8493 58082 Syva Emit Test Kit 1304 Digoxin 7 HIGH July 26, 1993
8503 67011 Ventrex Coated Tube RIA 1304 Digoxin 7 HIGH July 26, 1993
8505 K924594 70160 Wallac Oy DELFIA Digoxin Kit 1304 Digoxin 7 HIGH November 22, 1993
8509 4275 Ames OPTIMATE 1305 Disopyramide 7 HIGH July 26, 1993
8512 28183 Instrumentation Laboratory Multistat III 1305 Disopyramide 7 HIGH July 26, 1993
8513 28184 Instrumentation Laboratory Multistat III Plus 1305 Disopyramide 7 HIGH July 26, 1993
8520 4112 All Immunohematology Donor/Recipient Compatibility Procedures 1306 Donor/Recipient Compatibility 5 HIGH July 26, 1993
8521 E990015 34109 KMI Diagnostics TriCat 1322 Dopamine 6 HIGH April 2, 1999
8522 7280 Bio-Rad REMEDi Drug Profiling System 1307 Drugs of Abuse 7 HIGH July 26, 1993
8523 K941596 7604 Bio-Rad REMEDi HS Drug Profiling System 1307 Drugs of Abuse 7 HIGH April 7, 1995
8524 7300 Bioanalytical Systems BAS 200A 1307 Drugs of Abuse 7 HIGH July 26, 1993
8525 7301 Bioanalytical Systems BAS 480 1307 Drugs of Abuse 7 HIGH July 26, 1993
8526 7302 Bioanalytical Systems BAS 481 1307 Drugs of Abuse 7 HIGH July 26, 1993
8527 7307 Bioanalytical Systems BAS 482 1307 Drugs of Abuse 7 HIGH July 26, 1993
8529 61055 TOXI-LAB A Drug Detection System 1307 Drugs of Abuse 7 HIGH July 26, 1993
8530 61057 TOXI-LAB B Drug Detection System 1307 Drugs of Abuse 7 HIGH July 26, 1993
8531 61056 TOXI-LAB Drug Detection System A-PLUS 1307 Drugs of Abuse 7 HIGH July 26, 1993
8532 61058 TOXI-LAB Drug Detection System B-PLUS 1307 Drugs of Abuse 7 HIGH July 26, 1993
8533 61053 TOXI-LAB Special Procedure 1307 Drugs of Abuse 7 HIGH July 26, 1993
8534 61054 TOXI-LAB Validation Procedure 1307 Drugs of Abuse 7 HIGH July 26, 1993
8543 22029 Gamma STS-M Automated Blood Grouping Instrument 1308 Du (Weak D RBC antigen) 5 HIGH July 26, 1993
8547 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 1308 Du (Weak D RBC antigen) 5 HIGH July 26, 1993
8563 K933997 4530 Alexon-Trend ProSpecT Entamoeba histolytica (direct Ag/spectrophotometric) 1631 Entamoeba histolytica 11 HIGH February 3, 1995
8564 K933997 4529 Alexon-Trend ProSpecT Entamoeba histolytica (direct Ag/visual) 1631 Entamoeba histolytica 11 HIGH February 3, 1995
8566 K955895 61261 TechLab E. histolytica ELISA Test (spectrophotometric) 1631 Entamoeba histolytica 11 HIGH November 8, 1996
8567 K955895 61260 TechLab E. histolytica ELISA Test (visual) 1631 Entamoeba histolytica 11 HIGH November 8, 1996
8568 K944791 61169 TechLab Entamoeba Test (spectrophotometric) 1631 Entamoeba histolytica 11 HIGH March 17, 1995
8569 K944791 61168 TechLab Entamoeba Test (visual) 1631 Entamoeba histolytica 11 HIGH March 17, 1995
8570 37024 LMD Laboratories Amebiasis Microtiter ELISA (spectrophotometric) 1601 Entamoeba histolytica Antibodies 3 HIGH July 26, 1993
8571 37052 LMD Laboratories Amebiasis Microtiter ELISA (visual) 1601 Entamoeba histolytica Antibodies 3 HIGH July 26, 1993
8572 58191 Sigma Diagnostics SIA Amebiasis 1601 Entamoeba histolytica Antibodies 3 HIGH July 26, 1993
8573 K954996 61231 Trend Scientific TREND Amebiasis (E. histolytica) (spectrophotometric) 1601 Entamoeba histolytica Antibodies 3 HIGH August 16, 1996
8574 K954996 61232 Trend Scientific TREND Amebiasis (E. histolytica) (visual) 1601 Entamoeba histolytica Antibodies 3 HIGH August 16, 1996
8576 K951539 7715 Becton Dickinson Enterococcus Screening Test (including culture) 1612 Enterococcus 8 HIGH December 8, 1995
8577 22040 Gen-Probe AccuProbe (including culture) 1612 Enterococcus 8 HIGH July 26, 1993
8578 K940363 37086 Light Diagnostics MAb Enterovirus 70 (including culture) 1625 Enterovirus 70 10 HIGH September 15, 1995
8579 K940027 37084 Light Diagnostics MAb Enterovirus Blend (including culture) 1625 Enterovirus 70 10 HIGH September 15, 1995
8580 K940027 37084 Light Diagnostics MAb Enterovirus Blend (including culture) 1626 Enterovirus 71 10 HIGH September 15, 1995
8581 4353 All Manual Eosinophil Count Procedures 1616 Eosinophils 4 HIGH July 26, 1993
8583 E990018 34107 KMI Diagnostics 125 I-Adrenalin (125 I-Epinephrine) RIA 1638 Epinephrine (Adrenalin) 6 HIGH April 2, 1999
8584 E990020 34108 KMI Diagnostics Adrenalin (Epinephrine) ELISA 1638 Epinephrine (Adrenalin) 6 HIGH April 2, 1999
8585 E990016 34106 KMI Diagnostics KatCombi 1638 Epinephrine (Adrenalin) 6 HIGH April 2, 1999
8586 E990015 34109 KMI Diagnostics TriCat 1638 Epinephrine (Adrenalin) 6 HIGH April 2, 1999
8587 P950009 43128 NEOPATH AutoPap Primary Screening System 1637 Epithelial cells-cervical/vaginal (Papanicolaou) 13 HIGH April 2, 1999
8588 4294 Amico Amizyme EB-VCA Virus Antigen IgM Test (spectrophotometric) 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8589 4367 Amico Amizyme EB-VCA Virus Antigen IgM Test (visual) 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8590 4160 Amico Amizyme EBV Ab Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8591 K922332 7504 Baxter Bartels Epstein-Barr Virus IgG PRIMA System EIA 1603 Epstein-Barr virus Antibodies 3 HIGH November 22, 1993
8592 K922331 7503 Baxter Bartels Epstein-Barr Virus IgM PRIMA System EIA 1603 Epstein-Barr virus Antibodies 3 HIGH November 22, 1993
8593 7284 Baxter Bartels PRIMA Epstein Barr Virus IgM EIA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8594 7325 BioWhittaker EB VCA STAT 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8595 7326 BioWhittaker EB VCA STAT M 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8596 7327 BioWhittaker EBNA STAT 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8597 7328 BioWhittaker FIAX System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8598 7155 Bion EBV-G (VCA) Antibody Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8599 7156 Bion EBV-M (VCA) Antibody Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8602 13045 Diagnostic Technology EBNA Check 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8603 13046 Diagnostic Technology EBV Check 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8604 13047 Diagnostic Technology EBV/EA Check 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8605 13048 Diagnostic Technology EBV/IgM Check 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8606 K981829 13558 Diamedix Immunosimplicity (Is)-EBNA-1 IgG (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH May 24, 1999
8607 K982348 13574 Diamedix Immunosimplicity (Is)-EBNA-1 IgM (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH November 19, 1999
8608 K981831 13564 Diamedix Immunosimplicity (Is)-EBV-EA-D IgG (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH October 8, 1999
8609 K982350 13576 Diamedix Immunosimplicity (Is)-EBV-EA-D IgM (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH November 19, 1999
8610 K982352 13578 Diamedix Immunosimplicity (Is)-EBV-VCA IgM (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH November 19, 1999
8617 K925688 19017 Fuller Laboratories EBV-EA IgG Ab IFA Kit 1603 Epstein-Barr virus Antibodies 3 HIGH May 20, 1994
8618 K925690 19018 Fuller Laboratories EBV-EBNA IFA Kit 1603 Epstein-Barr virus Antibodies 3 HIGH May 20, 1994
8619 K925689 19016 Fuller Laboratories EBV-VCA IgG Ab IFA Kit 1603 Epstein-Barr virus Antibodies 3 HIGH May 20, 1994
8624 K973941 22254 GenBio ImmunoWELL EBNA IgG Quantitative Test 1603 Epstein-Barr virus Antibodies 3 HIGH January 27, 2000
8625 K973940 22255 GenBio ImmunoWELL EBV VCA IgG Quantitative Test 1603 Epstein-Barr virus Antibodies 3 HIGH January 27, 2000
8626 K973939 22256 GenBio ImmunoWELL EBV VCA IgM Quantitative Test 1603 Epstein-Barr virus Antibodies 3 HIGH January 27, 2000
8629 22067 Granbio Inc. EBNA Anti-complement IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8630 K951822 22180 Granbio Inc. EBNA IgG EIA Kit 1603 Epstein-Barr virus Antibodies 3 HIGH March 1, 1996
8631 22068 Granbio Inc. Epstein-Barr EA IgG IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8632 22069 Granbio Inc. Epstein-Barr VCA IgG EIA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8633 22070 Granbio Inc. Epstein-Barr VCA IgG IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8634 22071 Granbio Inc. Epstein-Barr VCA IgM EIA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8635 22072 Granbio Inc. Epstein-Barr VCA IgM IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8636 K771062 22077 Gull Laboratories EBV IFA Antibodies Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8637 K910872 22078 Gull Laboratories EBV IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8638 K910042 22079 Gull Laboratories EBV IgM ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8639 K822734 22080 Gull Laboratories EBV IgM IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8640 K872617 22081 Gull Laboratories EBV-EA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8641 K940093 22172 Gull Laboratories EBV-EA(D) IgG ELISA (qualitative) 1603 Epstein-Barr virus Antibodies 3 HIGH September 22, 1995
8642 K940093 22169 Gull Laboratories EBV-EA(D) IgG ELISA (quantitative) 1603 Epstein-Barr virus Antibodies 3 HIGH September 22, 1995
8643 K880043 22082 Gull Laboratories EBV-NA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8644 25040 Hillcrest Biologicals EBNA Ab IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8645 25041 Hillcrest Biologicals EBV Early Antigen IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8646 25043 Hillcrest Biologicals EBV VCA(IgG) IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8647 25042 Hillcrest Biologicals EBV VCA(IgM) IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8648 28133 Immuno Concepts Colorzyme EA Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8649 28134 Immuno Concepts Colorzyme EBNA Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8650 28136 Immuno Concepts Colorzyme EBV-VCA IgG Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8651 28135 Immuno Concepts Colorzyme EBV-VCA IgM Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8652 28145 Immuno Concepts EBNA Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8653 28139 Immuno Concepts EBV-EA Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8654 28142 Immuno Concepts EBV-VCA IgG Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8655 28140 Immuno Concepts EBV-VCA IgM Ab Test System 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8656 K951549 28411 Immuno Probe EBNA IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH May 3, 1996
8657 28225 Incstar Clin-ELISA Epstein-Barr EBNA IgG 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8658 28226 Incstar Clin-ELISA Epstein-Barr EBNA IgM 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8659 28223 Incstar Clin-ELISA Epstein-Barr VCA IgG 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8660 28224 Incstar Clin-ELISA Epstein-Barr VCA IgM 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8661 K946158 28372 Incstar EBNA IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH June 16, 1995
8662 K946159 28371 Incstar EBV VCA IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH June 16, 1995
8663 K946157 28373 Incstar EBV VCA IgM ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH June 16, 1995
8664 K946353 40202 MRL Diagnostics EBNA RIFA Antibody Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 28, 1995
8665 K931520 40194 MRL Diagnostics Epstein-Barr Virus rVCA IgM 1603 Epstein-Barr virus Antibodies 3 HIGH June 10, 1994
8666 46024 Organon Teknika EB-VCA IFA Kit II 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8667 46025 Organon Teknika EBNA ACIF Kit 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8668 46026 Organon Teknika EBV-EA IFA Kit 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8669 46027 Organon Teknika EBV-M Kit 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8670 46058 Ortho EBNA IgG Antibody ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8671 K931443 46146 Ortho Epstein-Barr Virus EA(D+R)-IgG Antibody ELISA Test 1603 Epstein-Barr virus Antibodies 3 HIGH May 20, 1994
8672 K930020 46142 Ortho Epstein-Barr Virus EBNA-IgG Antibody ELISA Test 1603 Epstein-Barr virus Antibodies 3 HIGH November 22, 1993
8673 46066 Ortho Epstein-Barr Virus VCA-IgG Antibody ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8674 46067 Ortho Epstein-Barr Virus VCA-IgM Antibody ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8675 49022 Pharmacia Epstein Barr Virus Viral Capsid Antigen IgM ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8676 K991975 52117 Quest International SeraQuest EB NA IgG (qualitative) 1603 Epstein-Barr virus Antibodies 3 HIGH December 10, 1999
8677 K991975 52118 Quest International SeraQuest EB NA IgG (semi-quantitative) 1603 Epstein-Barr virus Antibodies 3 HIGH December 10, 1999
8678 K990410 52115 Quest International SeraQuest EB VCA IgG (qualitative) 1603 Epstein-Barr virus Antibodies 3 HIGH December 10, 1999
8679 K990410 52116 Quest International SeraQuest EB VCA IgG (semi-quantitative) 1603 Epstein-Barr virus Antibodies 3 HIGH December 10, 1999
8680 K990977 52114 Quest International SeraQuest EB VCA IgM 1603 Epstein-Barr virus Antibodies 3 HIGH November 1, 1999
8685 58173 Sigma Diagnostics SIA Epstein-Barr EBNA IgM/IgG 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8686 58175 Sigma Diagnostics SIA Epstein-Barr VCA IgG 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8687 67020 Virgo Epstein-Barr Virus - VCA Antibody IFA Test 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8688 K933251 67085 Virion EBV Combi Test 1603 Epstein-Barr virus Antibodies 3 HIGH October 14, 1994
8689 K932742 79048 Zeus Scientific EBNA IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH August 4, 1995
8690 79006 Zeus Scientific EBV-EA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8691 79035 Zeus Scientific EBV-NA (ACIF) Ab 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8692 79030 Zeus Scientific EBV-VCA IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8693 K924091 79039 Zeus Scientific EBV-VCA IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH November 22, 1993
8694 79031 Zeus Scientific EBV-VCA IgM Antibody IFA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
8695 K944449 79046 Zeus Scientific EBV-VCA IgM ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH September 29, 1995
8696 K981120 79065 Zeus Scientific Epstein-Barr Virus (EBV) Early Antigen (EA) IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH January 22, 1999
8707 13190 Diagnostic Systems Erythropoietin (EPO) RIA Kit 1611 Erythropoietin 6 HIGH July 26, 1993
8708 K926390 22159 Genzyme Predicta Erythropoietin Kit 1611 Erythropoietin 6 HIGH November 22, 1993
8709 28201 Incstar EPO-Trac 1611 Erythropoietin 6 HIGH July 26, 1993
8711 K932650 43100 Nichols Institute Chemiluminescence Erythropoietin Assay 1611 Erythropoietin 6 HIGH October 14, 1994
8712 55111 R & D Systems Clinigen Erythopoietin EIA 1611 Erythropoietin 6 HIGH July 26, 1993
8713 K931666 55114 R & D Systems Quantikine Erythropoietin ELISA 1611 Erythropoietin 6 HIGH November 22, 1993
8714 K936016 55132 R & D Systems Quantikine IVD Erythropoietin ELISA 1611 Erythropoietin 6 HIGH September 30, 1994
8715 55089 Ramco Laboratories EPORIA Test Kit 1611 Erythropoietin 6 HIGH July 26, 1993
8717 K980507 4793 Alexon-Trend ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay (spectrophotometric) 1604 Escherichia coli 8 HIGH June 5, 1998
8718 K980507 4792 Alexon-Trend ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay (visual) 1604 Escherichia coli 8 HIGH June 5, 1998
8719 7201 Becton Dickinson BBL Eschericia coli (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8720 7131 Bio-Medical ANI E. coli 0157 Test (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8721 13126 Difco Bacto E. coli O (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8722 13117 Difco Bacto E. coli O 0157 (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8723 K942705 37092 LMD Laboratories E. coli 0157 ELISA Assay (direct Ag/spectrophotometric) 1604 Escherichia coli 8 HIGH October 13, 1995
8724 K942705 37091 LMD Laboratories E. coli 0157 ELISA Assay (direct Ag/visual) 1604 Escherichia coli 8 HIGH October 13, 1995
8725 K962028 40262 Murex Wellcolex E. coli 0157 Rapid Latex (including culture) 1604 Escherichia coli 8 HIGH February 14, 1997
8726 K971663 40268 Murex Wellcolex E. coli 0157:H7 Rapid Latex (including culture) 1604 Escherichia coli 8 HIGH January 2, 1998
8727 49010 Pro-Lab Diagnostics E.coli 0157 LA Test (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8728 K933457 55125 Remel E. coli 0157:H7 Latex Test (including culture) 1604 Escherichia coli 8 HIGH June 10, 1994
8729 55092 Roach Laboratories E. coli OK (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8730 K973457 58510 Shared Systems Chromalex E. coli 0157 Latex Agglutination Test System 1604 Escherichia coli 8 HIGH May 15, 1998
8731 64003 Unipath Oxoid E. coli 0157 Latex Kit (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
8735 E990039 4862 Alfa Scientific Designs Estradiol (E2) EIA 1605 Estradiol 6 HIGH July 23, 1999
8744 K931740 7138 Bio-Rad CoTube 1605 Estradiol 6 HIGH November 22, 1993
8745 7141 Bio-Rad Quantimune 1605 Estradiol 6 HIGH July 26, 1993
8746 7256 Biomerica RIA Test Kit 1605 Estradiol 6 HIGH July 26, 1993
8757 K941168 10060 Clinical Assays GammaCoat 1605 Estradiol 6 HIGH October 28, 1994
8760 13030 Diagnostic Products Corp. Coat-A-Count 1605 Estradiol 6 HIGH July 26, 1993
8761 K943193 13317 Diagnostic Products Corp. Coat-A-Count Estradiol-6 1605 Estradiol 6 HIGH March 3, 1995
8762 13031 Diagnostic Products Corp. Double Antibody 1605 Estradiol 6 HIGH July 26, 1993
8763 13111 Diagnostic Products Corp. Milenia 1605 Estradiol 6 HIGH July 26, 1993
8764 13192 Diagnostic Systems Estradiol RIA Kit 1605 Estradiol 6 HIGH July 26, 1993
8765 K953605 13412 Diagnostic Systems Ultra Sensitive Estradiol RIA 1605 Estradiol 6 HIGH March 8, 1996
8767 K973901 34104 KMI Diagnostics 17 Beta-Estradiol ELISA 1605 Estradiol 6 HIGH April 2, 1999
8768 37029 Leeco Diagnostics RIA Test Kit 1605 Estradiol 6 HIGH July 26, 1993
8778 58091 Serono Baker Serozyme 1605 Estradiol 6 HIGH July 26, 1993
8780 58251 Serono Diagnostics Serozyme 1605 Estradiol 6 HIGH July 26, 1993
8788 70148 Wallac Oy DELFIA Estradiol Kit 1605 Estradiol 6 HIGH September 1, 1994
8792 4146 Amersham Amerlex 1606 Estriol, Total 6 HIGH July 26, 1993
8793 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1606 Estriol, Total 6 HIGH July 26, 1993
8794 7142 Bio-Rad Quantimune II 1606 Estriol, Total 6 HIGH July 26, 1993
8795 10061 Clinical Assays GammaDab 1606 Estriol, Total 6 HIGH July 26, 1993
8796 13030 Diagnostic Products Corp. Coat-A-Count 1606 Estriol, Total 6 HIGH July 26, 1993
8797 13195 Diagnostic Systems Total Estriol RIA Kit 1606 Estriol, Total 6 HIGH July 26, 1993
8801 4146 Amersham Amerlex 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8804 7256 Biomerica RIA Test Kit 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8805 13030 Diagnostic Products Corp. Coat-A-Count 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8806 K955356 13409 Diagnostic Systems Active Ultra-Senstive Unconjugated Estriol 1607 Estriol, unconjugated 6 HIGH May 24, 1996
8807 K962875 13434 Diagnostic Systems DSL-10-3700 ACTIVE Unconj. Estriol EIA 1607 Estriol, unconjugated 6 HIGH October 18, 1996
8808 13198 Diagnostic Systems Ultra-Sensitive Unconjugated Estriol RIA Kit 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8809 28172 Immunotech ENDAB EIA Kit 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8810 28175 Immunotech Microzyme EIA (spectrophotometric) 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8811 E990023 34099 KMI Diagnostics Estriol unconjugated (uE3) ELISA 1607 Estriol, unconjugated 6 HIGH March 26, 1999
8812 40085 Micromedic Systems CONCEPT 4 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8813 40111 Micromedic Systems Concept 4 Plus 1607 Estriol, unconjugated 6 HIGH July 26, 1993
8815 K935013 13314 Diagnostic Systems Estrone RIA Kit 1628 Estrone 6 HIGH October 14, 1994
8816 K970915 13461 Diagnostic Systems DSL-5400 Estrone-Sulfate RIA 1633 Estrone Sulfate 6 HIGH July 25, 1997
8823 7383 Beckman Auto ICS 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8824 7381 Beckman ICS 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8825 7382 Beckman ICS II 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8865 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8879 16010 Electronucleonics FLEXIGEM 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8888 28183 Instrumentation Laboratory Multistat III 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8889 28184 Instrumentation Laboratory Multistat III Plus 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8911 55075 Reagents Applications RAICHEM Test Kit (manual) 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8940 58051 Sigma Diagnostics Test Kit 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8941 58188 Syva Emit st Drug Detection System 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
8953 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 1629 Ethanolamine 2 HIGH November 10, 1994
8956 4275 Ames OPTIMATE 1609 Ethosuximide 7 HIGH July 26, 1993
8957 4156 Ames TDA 1609 Ethosuximide 7 HIGH July 26, 1993
8969 28183 Instrumentation Laboratory Multistat III 1609 Ethosuximide 7 HIGH July 26, 1993
8970 28184 Instrumentation Laboratory Multistat III Plus 1609 Ethosuximide 7 HIGH July 26, 1993
8975 58082 Syva Emit Test Kit 1609 Ethosuximide 7 HIGH July 26, 1993
8979 28183 Instrumentation Laboratory Multistat III 1615 Ethylene Glycol 7 HIGH July 26, 1993
8980 28184 Instrumentation Laboratory Multistat III Plus 1615 Ethylene Glycol 7 HIGH July 26, 1993
8981 13134 Diagnostica Stago ASSERACHROM IX:Ag 1917 Factor IX Antigen 4 HIGH July 26, 1993
8982 13142 Diagnostica Stago Assera-Plate IX:Ag 1917 Factor IX Antigen 4 HIGH July 26, 1993
8984 25031 Helena Laboratories Factor VIII Related Antigen Rocket System 1915 Factor VIII Related Antigen 4 HIGH July 26, 1993
8985 28155 International Immunoassay Labs EIA-F8 Kit 1915 Factor VIII Related Antigen 4 HIGH July 26, 1993
8986 28184 Instrumentation Laboratory Multistat III Plus 1920 Factor X 4 HIGH July 26, 1993
8987 58229 Sterling Diagnostics Analyzer 2000 1919 Fatty Acids, Non-Esterified 2 HIGH July 26, 1993
8988 70117 Wako NEFA C Test Kit 1919 Fatty Acids, Non-Esterified 2 HIGH July 26, 1993
9034 13030 Diagnostic Products Corp. Coat-A-Count 1913 Fentanyl 7 HIGH July 26, 1993
9039 4146 Amersham Amerlex 1902 Ferritin 2 HIGH July 26, 1993
9040 4148 Amersham Amerlite 1902 Ferritin 2 HIGH July 26, 1993
9047 7247 Becton Dickinson MAb Solid Phase Component System 1902 Ferritin 2 HIGH July 26, 1993
9048 7102 Becton Dickinson Monoclonal Solid Phase Coated Tube 1902 Ferritin 2 HIGH July 26, 1993
9057 7141 Bio-Rad Quantimune 1902 Ferritin 2 HIGH July 26, 1993
9060 K992517 8232 BioCheck Ferritin ELISA 1902 Ferritin 2 HIGH November 1, 1999
9074 10051 Ciba Corning Magic (MGC) 1902 Ferritin 2 HIGH July 26, 1993
9075 10055 Ciba Corning Magic Lite 1902 Ferritin 2 HIGH July 26, 1993
9078 10060 Clinical Assays GammaCoat 1902 Ferritin 2 HIGH July 26, 1993
9079 10061 Clinical Assays GammaDab 1902 Ferritin 2 HIGH July 26, 1993
9086 13030 Diagnostic Products Corp. Coat-A-Count 1902 Ferritin 2 HIGH July 26, 1993
9087 13109 Diagnostic Products Corp. Coat-A-Count IRMA 1902 Ferritin 2 HIGH July 26, 1993
9088 13031 Diagnostic Products Corp. Double Antibody 1902 Ferritin 2 HIGH July 26, 1993
9089 13180 Diagnostic Systems Active Ferritin IRMA Kit 1902 Ferritin 2 HIGH July 26, 1993
9093 13091 Du Pont RIANEN RIA Kit 1902 Ferritin 2 HIGH July 26, 1993
9094 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 1902 Ferritin 2 HIGH July 26, 1993
9095 25053 Hybritech Photon Immunoassay Analyzer 1902 Ferritin 2 HIGH July 26, 1993
9096 25022 Hybritech Tandem-E 1902 Ferritin 2 HIGH July 26, 1993
9097 25023 Hybritech Tandem-R 1902 Ferritin 2 HIGH July 26, 1993
9098 K895872 31016 Johnson & Johnson CDL Amerlite Analyzer 1902 Ferritin 2 HIGH January 27, 2000
9100 37029 Leeco Diagnostics RIA Test Kit 1902 Ferritin 2 HIGH July 26, 1993
9101 40117 Medix Biotech EIA Test Kit 1902 Ferritin 2 HIGH July 26, 1993
9103 43008 Nichols Institute Allegro RIA 1902 Ferritin 2 HIGH July 26, 1993
9104 43067 Nichols Institute Chemiluminescence Ferritin Assay 1902 Ferritin 2 HIGH September 1, 1994
9112 55087 Ramco Laboratories FER-IRON II Microtiter Assay Kit 1902 Ferritin 2 HIGH July 26, 1993
9113 55010 Ramco Laboratories RIA Test Kit 1902 Ferritin 2 HIGH July 26, 1993
9115 K920829 55123 Roche Diagnostics Cobas Core Ferritin EIA (manual) 1902 Ferritin 2 HIGH November 22, 1993
9138 K970612 58451 SeaLite Sciences AquaLite Ferritin (computer calculations) 1902 Ferritin 2 HIGH July 11, 1997
9141 58091 Serono Baker Serozyme 1902 Ferritin 2 HIGH July 26, 1993
9143 58251 Serono Diagnostics Serozyme 1902 Ferritin 2 HIGH July 26, 1993
9149 K951993 64032 United Biotech UBI MAGIWEL Ferritin Quantitative 1902 Ferritin 2 HIGH September 8, 1995
9151 70161 Wallac Oy DELFIA Ferritin Kit 1902 Ferritin 2 HIGH September 1, 1994
9154 K980314 8124 BCA Fetal D Tection Kit 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH August 21, 1998
9155 13081 Du procedures with microscopic exam for mixed field agglut. 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9156 22016 Gamma Fetal Bleed Screening Test 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9157 28051 Indicator Cell Rosette Test - screen for fetal RBC's 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9158 40103 Modified Kleihauer-Betke Acid Elution Stain Procedure 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9159 46068 Ortho FETALSCREEN 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9160 58126 Sigma Diagnostics Fetal Hemoglobin Kit 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9161 58127 Simmler, Inc. Fetal Cell Stain Kit 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9162 58261 Sure-Tech Fetal Hemoglobin Kit 1903 Fetal RBCs - Maternal Blood (fetal-maternal bleed) 5 HIGH July 26, 1993
9165 49106 Protamine Sulfate (with serial dilutions) 1927 Fibrin Monomers 4 HIGH September 12, 1994
9178 46112 Organon Teknika Fibrinostika FbDP Microelisa System 1904 Fibrin(ogen) Split/Degradation Products (FSP/FDP) 4 HIGH July 26, 1993
9179 K924892 46225 Organon Teknika Fibrinostika FgDP Microelisa System 1904 Fibrin(ogen) Split/Degradation Products (FSP/FDP) 4 HIGH January 10, 1997
9181 58222 Sigma Diagnostics Fibrin/Fibrinogen Degradation Products 1904 Fibrin(ogen) Split/Degradation Products (FSP/FDP) 4 HIGH July 26, 1993
9185 4424 All Manual Tilt-Tube Coagulation Procedures 1905 Fibrinogen 4 HIGH September 12, 1994
9186 K970189 4775 American Biogenetic Sciences FiF Test 1905 Fibrinogen 4 HIGH February 20, 1998
9199 K934326 7545 Behring Multifibren U (manual) 1905 Fibrinogen 4 HIGH October 14, 1994
9203 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1905 Fibrinogen 4 HIGH July 26, 1993
9206 7696 Bio/Data MCA 210 (von Clauss Methodology) 1905 Fibrinogen 4 HIGH October 20, 1995
9208 K943153 7697 Bio/Data MCA 310 (von Clauss Methodology) 1905 Fibrinogen 4 HIGH October 20, 1995
9221 K941001 13319 Diagnostic Specialties EnZIP Immunoturbidometric (manual) 1905 Fibrinogen 4 HIGH October 28, 1994
9232 K926222 25152 Helena Laboratories Fibrinogen Assay Kit (manual) 1905 Fibrinogen 4 HIGH November 22, 1993
9257 28183 Instrumentation Laboratory Multistat III 1905 Fibrinogen 4 HIGH July 26, 1993
9258 28184 Instrumentation Laboratory Multistat III Plus 1905 Fibrinogen 4 HIGH July 26, 1993
9282 46118 Organon Teknika Fibriquik 1905 Fibrinogen 4 HIGH July 26, 1993
9288 K992130 49232 Pacific Hemostasis ThromboScreen 400C (von Clauss methodology) 1905 Fibrinogen 4 HIGH January 28, 2000
9310 K955724 58411 Sigma Diagnostics Amelung KC 1 A Coagulation Analyzer 1905 Fibrinogen 4 HIGH August 30, 1996
9311 K955735 58412 Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer 1905 Fibrinogen 4 HIGH August 30, 1996
9320 K922416 61101 The Binding Site Human Fibrinogen RID 1905 Fibrinogen 4 HIGH November 22, 1993
9323 13132 Diagnostica Stago ASSERACHROM FPA 1916 Fibrinopeptide A 4 HIGH July 26, 1993
9324 28183 Instrumentation Laboratory Multistat III 1921 Fibronectin 4 HIGH July 26, 1993
9325 28184 Instrumentation Laboratory Multistat III Plus 1921 Fibronectin 4 HIGH July 26, 1993
9328 7379 Beckman Lumadex - FSI 1922 Foam Stability Index 2 HIGH July 26, 1993
9336 7106 Becton Dickinson SimulTRAC 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9337 7107 Becton Dickinson SimulTRAC S 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9338 7108 Becton Dickinson SimulTRAC SNB 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9339 7354 Bio-Rad Quantaphase 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9340 K935286 7532 Bio-Rad Quantaphase II 1907 Folate (Folic acid) 2 HIGH September 30, 1994
9347 10051 Ciba Corning Magic (MGC) 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9348 10054 Ciba Corning Magic Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9349 10055 Ciba Corning Magic Lite 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9350 10057 Ciba Corning Magic/NB (no boil) 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9353 10062 Clinical Assays NO-Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9354 10063 Clinical Assays Solid Phase 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9358 13028 Diagnostic Products Corp. Charcoal Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9359 13032 Diagnostic Products Corp. Dualcount Charcoal 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9360 13034 Diagnostic Products Corp. Dualcount Solid Phase Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9361 13041 Diagnostic Products Corp. Solid Phase No Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9362 40083 Micromedic Combostat II 1907 Folate (Folic acid) 2 HIGH July 26, 1993
9382 K972232 4532 Abbott AxSYM 1930 Folate, Red Blood Cell (RBC Folate) 2 HIGH January 23, 1998
9384 K954332 8120 Bayer Immuno 1 System (manual calculations) 1930 Folate, Red Blood Cell (RBC Folate) 2 HIGH August 21, 1998
9391 K984166 46279 Ortho-Clinical Diagnostics Vitros ECi 1930 Folate, Red Blood Cell (RBC Folate) 2 HIGH June 4, 1999
9393 K954332 61230 Technicon Immuno 1 (manual calculations) 1930 Folate, Red Blood Cell (RBC Folate) 2 HIGH March 15, 1996
9399 K972720 4844 Alfa Scientific Designs Follicle Stimulating Hormone (FSH) EIA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 23, 1999
9401 4148 Amersham Amerlite 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9409 7106 Becton Dickinson SimulTRAC 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9429 13109 Diagnostic Products Corp. Coat-A-Count IRMA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9430 13031 Diagnostic Products Corp. Double Antibody 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9431 13111 Diagnostic Products Corp. Milenia 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9432 K962118 13432 Diagnostic Systems DSL-4700 ACTIVE FSH IRMA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH October 4, 1996
9438 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9439 25053 Hybritech Photon Immunoassay Analyzer 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9440 25022 Hybritech Tandem-E 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9441 28213 ICN IMMUNOCHEM FSH-MW ELISA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9442 28174 Immunotech EZ-TUBE EIA Kit 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9443 K952285 31016 Johnson & Johnson CDL Amerlite Analyzer 1908 Follicle Stimulating Hormone (FSH) 6 HIGH August 18, 1995
9445 37029 Leeco Diagnostics RIA Test Kit 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9446 40117 Medix Biotech EIA Test Kit 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9447 K972720 40284 Monobind Follicle Stimulating Hormone (FSH) ELISA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH February 20, 1998
9448 43008 Nichols Institute Allegro RIA 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9449 43066 Nichols Institute Chemiluminescence FSH Assay 1908 Follicle Stimulating Hormone (FSH) 6 HIGH September 1, 1994
9450 46007 Organon NML IRMA Test Kit 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9456 K930304 55124 Roche Diagnostics Cobas Core FSH EIA (manual) 1908 Follicle Stimulating Hormone (FSH) 6 HIGH May 25, 1994
9462 K970085 58437 SeaLite Sciences AquaLite FSH (computer calculations) 1908 Follicle Stimulating Hormone (FSH) 6 HIGH March 7, 1997
9463 K943437 58342 SeaLite Sciences AquaLite FSH (manual curve) 1908 Follicle Stimulating Hormone (FSH) 6 HIGH December 9, 1994
9465 58091 Serono Baker Serozyme 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9467 58251 Serono Diagnostics Serozyme 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
9477 70149 Wallac Oy DELFIA hFSH Kit 1908 Follicle Stimulating Hormone (FSH) 6 HIGH September 1, 1994
9498 28181 Isolab Glyco-PROBE GSP 1914 Fructosamine 2 HIGH July 26, 1993
9502 K993590 49227 Pointe Scientific Fructosamine 1914 Fructosamine 2 HIGH January 7, 2000
9503 55075 Reagents Applications RAICHEM Test Kit (manual) 1914 Fructosamine 2 HIGH July 26, 1993
9524 4322 All Fungal Identification from Culture 1909 Fungi 12 HIGH July 26, 1993
9528 K960090 55206 Remel Calcofluor White Stain Kit 1910 Fungi - Fungal elements only 12 HIGH May 17, 1996
9529 28029 Immuno-Mycologics ID-Fungal Antibody System 1912 Fungus Antibodies 3 HIGH July 26, 1993
9531 40062 Meridian Diagnostics Fungal Immunodiffusion System 1912 Fungus Antibodies 3 HIGH July 26, 1993
9532 K894011 4781 Astoria-Pacific SPOTCHECK Analyzer 2223 Galactose, Total 2 HIGH April 3, 1998
9533 K951329 28390 ICN ImmuChem Galactose Microwell Enzyme Assay 2223 Galactose, Total 2 HIGH November 24, 1995
9534 K950481 28367 Isolab Fluoroscan II Neonatal Chemistry System 2223 Galactose, Total 2 HIGH February 9, 1996
9535 K984463 52111 Quantase Phe/Gal (Newborn) Screening Assay 2223 Galactose, Total 2 HIGH July 23, 1999
9536 K990644 52120 Quantase Total Galactose (Newborn) Screening Assay 2223 Galactose, Total 2 HIGH January 7, 2000
9537 K970277 4696 Astoria-Pacific API 300 SPOTCHECK System 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH December 19, 1997
9538 K970277 4781 Astoria-Pacific SPOTCHECK Analyzer 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH April 3, 1998
9539 K993536 8255 Bio-Rad CODA Neonatal GALT 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH January 18, 2000
9540 K990827 8190 Bio-Rad Microplate Neonatal GALT 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH April 23, 1999
9541 K950803 28367 Isolab Fluoroscan II Neonatal Chemistry System 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH September 29, 1995
9542 58051 Sigma Diagnostics Test Kit 2215 Galactose-1-Phosphate Uridyl Transferase 2 HIGH July 26, 1993
9546 4035 Abbott Bichromatic ABA 100 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9547 4036 Abbott Bichromatic ABA 200 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9548 4267 Abbott Bichromatic ABA 50 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9560 4144 American Monitor Parallel 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9561 4275 Ames OPTIMATE 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9566 7378 Beckman Manual Spectrophotometric Test Procedure 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9614 K945800 13395 Diagnostic Chemicals GGT Assay Kit (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH August 4, 1995
9634 K946192 25182 HiChem Gamma-GT Reagent Kit (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH May 5, 1995
9635 K881239 25200 Horizon Gamma Glutamyl Transpeptidase (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH April 28, 1995
9642 28183 Instrumentation Laboratory Multistat III 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9643 28184 Instrumentation Laboratory Multistat III Plus 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9661 K923091 34051 King Diagnostics Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH September 1, 1994
9673 40124 Medical Analysis Systems RefLab Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9674 40118 Meditech Diagnostic System Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9699 49064 Pointe Scientific 180 Chemistry Analyzer 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9701 55106 Randox Laboratories Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9702 55075 Reagents Applications RAICHEM Test Kit (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9727 58051 Sigma Diagnostics Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9728 58157 Stanbio Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9729 58229 Sterling Diagnostics Analyzer 2000 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9730 58230 Sterling Diagnostics Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9732 K931958 58260 Synermed Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH May 20, 1994
9733 K881626 61411 TECO Diagnostics Gamma Glutamyl Transferase (GGT) Reagent Set (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH March 26, 1999
9734 K882938 61377 TECO Diagnostics TC 84 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH November 19, 1998
9747 61016 Technicon SMAC 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9748 61045 Technicon SMAC 2 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9749 61046 Technicon SMAC 3 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9751 70102 Wako Autokit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
9754 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2220 Gamma-Aminobutyric Acid 2 HIGH November 10, 1994
9760 K961276 7786 Biosyn Gastrin EIA 2205 Gastrin 6 HIGH July 12, 1996
9761 13031 Diagnostic Products Corp. Double Antibody 2205 Gastrin 6 HIGH July 26, 1993
9762 K961276 28444 ICN Gastrin EIA 2205 Gastrin 6 HIGH July 12, 1996
9765 4275 Ames OPTIMATE 2202 Gentamicin 7 HIGH July 26, 1993
9766 4156 Ames TDA 2202 Gentamicin 7 HIGH July 26, 1993
9773 7383 Beckman Auto ICS 2202 Gentamicin 7 HIGH July 26, 1993
9774 7381 Beckman ICS 2202 Gentamicin 7 HIGH July 26, 1993
9775 7382 Beckman ICS II 2202 Gentamicin 7 HIGH July 26, 1993
9809 13030 Diagnostic Products Corp. Coat-A-Count 2202 Gentamicin 7 HIGH July 26, 1993
9825 28183 Instrumentation Laboratory Multistat III 2202 Gentamicin 7 HIGH July 26, 1993
9826 28184 Instrumentation Laboratory Multistat III Plus 2202 Gentamicin 7 HIGH July 26, 1993
9857 K930451 4585 Alexon-Trend ProSpecT Giardia EZ Microplate Assay (direct Ag/spectrophotometric) 2222 Giardia lamblia 11 HIGH December 23, 1994
9858 K930451 4586 Alexon-Trend ProSpecT Giardia EZ Microplate Assay (direct Ag/visual) 2222 Giardia lamblia 11 HIGH December 23, 1994
9859 K942098 4557 Alexon-Trend ProSpecT Giardia Microplate Assay (direct Ag/spectrophotometric) 2222 Giardia lamblia 11 HIGH February 3, 1995
9860 K942098 4558 Alexon-Trend ProSpecT Giardia Microplate Assay (direct Ag/visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
9861 4257 Alexon-Trend ProSpecT Giardia Microtiter (direct Ag/spectrophotometric) 2222 Giardia lamblia 11 HIGH February 3, 1995
9863 K955157 4655 Alexon-Trend ProSpecT Giardia/Crypto. Microplate (direct Ag/spectrophotometric) 2222 Giardia lamblia 11 HIGH March 1, 1996
9864 K955157 4654 Alexon-Trend ProSpecT Giardia/Crypto. Microplate (direct Ag/visual) 2222 Giardia lamblia 11 HIGH March 1, 1996
9865 4338 Alexon-Trend ProSpecT/Giardia (tube) (dir Ag/visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
9866 4224 Antibodies Inc. GiardEIA (direct Ag/visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
9870 37032 LMD Laboratories G. lamblia Ag Detect. Microtiter (spectrophotometric) 2222 Giardia lamblia 11 HIGH February 3, 1995
9871 37019 LMD Laboratories G. lamblia Ag Detect. Microtiter (visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
9872 40095 Meridian Diagnostics MERIFLUOR Cryptosporidium/Giardia 2222 Giardia lamblia 11 HIGH February 3, 1995
9873 40099 Meridian Diagnostics MERIFLUOR Giardia 2222 Giardia lamblia 11 HIGH February 3, 1995
9874 58296 Seradyn Color Vue - Giardia (direct Ag/visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
9875 K912152 61218 TechLab CeLLabs Giardia-Cel IF Test 2222 Giardia lamblia 11 HIGH November 9, 1995
9876 K963135 61277 TechLab GIARDIA TEST 2222 Giardia lamblia 11 HIGH March 14, 1997
9877 K953284 61204 Trend Scientific Giardia Direct Detection RS Test 2222 Giardia lamblia 11 HIGH October 13, 1995
9878 K890003 61019 Trend Scientific Giardia lamblia Direct Detection System 2222 Giardia lamblia 11 HIGH February 3, 1995
9880 58051 Sigma Diagnostics Test Kit 2214 Globulin, Total 3 HIGH July 26, 1993
9888 4035 Abbott Bichromatic ABA 100 2203 Glucose 2 HIGH July 26, 1993
9889 4036 Abbott Bichromatic ABA 200 2203 Glucose 2 HIGH July 26, 1993
9890 4267 Abbott Bichromatic ABA 50 2203 Glucose 2 HIGH July 26, 1993
9902 4143 American Monitor KDA 2203 Glucose 2 HIGH July 26, 1993
9903 4144 American Monitor Parallel 2203 Glucose 2 HIGH July 26, 1993
9905 4275 Ames OPTIMATE 2203 Glucose 2 HIGH July 26, 1993
9917 7378 Beckman Manual Spectrophotometric Test Procedure 2203 Glucose 2 HIGH July 26, 1993
9964 13216 DMA Test Kit 2203 Glucose 2 HIGH July 26, 1993
9975 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 2203 Glucose 2 HIGH July 26, 1993
9988 16010 Electronucleonics FLEXIGEM 2203 Glucose 2 HIGH July 26, 1993
9996 K960084 25235 HiChem Glucose {HK Reagent Kit} (manual) 2203 Glucose 2 HIGH June 7, 1996
9997 K880236 25219 Horizon Glucose (Hexokinase) (manual) 2203 Glucose 2 HIGH April 28, 1995
10000 28157 Instrumentation Laboratory IL 504 2203 Glucose 2 HIGH July 26, 1993
10001 28158 Instrumentation Laboratory IL 508 2203 Glucose 2 HIGH July 26, 1993
10010 28183 Instrumentation Laboratory Multistat III 2203 Glucose 2 HIGH July 26, 1993
10011 28184 Instrumentation Laboratory Multistat III Plus 2203 Glucose 2 HIGH July 26, 1993
10031 K923129 34051 King Diagnostics Test Kit 2203 Glucose 2 HIGH July 26, 1993
10046 40124 Medical Analysis Systems RefLab Test Kit 2203 Glucose 2 HIGH July 26, 1993
10089 49064 Pointe Scientific 180 Chemistry Analyzer 2203 Glucose 2 HIGH July 26, 1993
10095 55075 Reagents Applications RAICHEM Test Kit (manual) 2203 Glucose 2 HIGH July 26, 1993
10119 58170 Sclavo Fast Glucose 2203 Glucose 2 HIGH July 26, 1993
10120 58033 Sclavo Manual Glucose Test Kit 2203 Glucose 2 HIGH July 26, 1993
10124 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 2203 Glucose 2 HIGH July 26, 1993
10125 58186 Seragen Quick-Chem 2203 Glucose 2 HIGH July 26, 1993
10126 58185 Seragen StatEase 2203 Glucose 2 HIGH July 26, 1993
10127 58051 Sigma Diagnostics Test Kit 2203 Glucose 2 HIGH July 26, 1993
10128 58195 SmithKline ESKALAB-CCS 2203 Glucose 2 HIGH July 26, 1993
10129 58066 Stanbio Manual Glucose Test Kit 2203 Glucose 2 HIGH July 26, 1993
10130 58210 Stanbio Premiere 2203 Glucose 2 HIGH July 26, 1993
10131 58157 Stanbio Test Kit 2203 Glucose 2 HIGH July 26, 1993
10133 58229 Sterling Diagnostics Analyzer 2000 2203 Glucose 2 HIGH July 26, 1993
10135 K882938 61377 TECO Diagnostics TC 84 2203 Glucose 2 HIGH November 19, 1998
10136 61044 TRACE Scientific Test Kit 2203 Glucose 2 HIGH July 26, 1993
10149 61015 Technicon SMA 6/60 2203 Glucose 2 HIGH July 26, 1993
10150 61016 Technicon SMAC 2203 Glucose 2 HIGH July 26, 1993
10151 61045 Technicon SMAC 2 2203 Glucose 2 HIGH July 26, 1993
10152 61046 Technicon SMAC 3 2203 Glucose 2 HIGH July 26, 1993
10156 70111 Wako Glucose C Test Kit 2203 Glucose 2 HIGH July 26, 1993
10289 4035 Abbott Bichromatic ABA 100 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH July 26, 1993
10290 4036 Abbott Bichromatic ABA 200 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH July 26, 1993
10293 K990957 4781 Astoria-Pacific SPOTCHECK Analyzer 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH June 11, 1999
10296 7225 Behring Stat-Pack G-6-PDH Test 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH July 26, 1993
10305 16010 Electronucleonics FLEXIGEM 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH July 26, 1993
10318 58051 Sigma Diagnostics Test Kit 2208 Glucose-6-Phosphate Dehydrogenase (G-6-PDH) 2 HIGH July 26, 1993
10323 25072 Helena Laboratories G-6-PD Electrophoresis 2210 Glucose-6-Phosphate Dehydrogenase Fractions 2 HIGH July 26, 1993
10324 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2217 Glutamic Acid 2 HIGH November 10, 1994
10325 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 2218 Glutamine 2 HIGH May 26, 1995
10328 58051 Sigma Diagnostics Test Kit 2213 Glutathione Reductase 2 HIGH July 26, 1993
10331 K802832 25201 Horizon Glycohemoglobin (manual) 2221 Glycated Hemoglobin, Total 2 HIGH April 28, 1995
10333 K980888 16191 Exocell GLYCACOR ELISA 2229 Glycated LDL 2 HIGH November 19, 1998
10334 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2219 Glycine 2 HIGH November 10, 1994
10335 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 2219 Glycine 2 HIGH May 26, 1995
10342 7371 Beckman Paragon Diatrac HbA1C Glycohemoglobin Electrophoresis Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10347 7124 Binax Equate Glycohemoglobin 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10348 7277 Bio-Rad Column Test 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10351 7781 Bio-Rad MDMS 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 12, 1996
10352 K942451 7778 Bio-Rad MDMS/CDMS 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH June 7, 1996
10363 10172 Chembio Glyco-Sep/A1c jr 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10364 10171 Chembio Glyco-Stat/A1/6 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10370 25080 Helena Laboratories GLYCO-Hb Quik Column Chromatography 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10371 25079 Helena Laboratories GLYCO-Tek Affinity Column Method 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10372 25116 Helena Laboratories Heme Spec Plus 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10373 25077 Helena Laboratories REP Glyco 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10374 28119 Isolab Glyc-Affin GHb 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10375 28179 Isolab Quik-Sep Fast Hemoglobin Test System 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10376 37069 LSI ASCA Chemistry System 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH September 1, 1994
10377 40118 Meditech Diagnostic System Test Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10378 49064 Pointe Scientific 180 Chemistry Analyzer 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10379 49114 Pointe Scientific Glycohemoglobin Test Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH October 28, 1994
10380 K942009 49129 Primus Rapid Gel Glycated Hemoglobin 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH January 20, 1995
10395 K963844 58428 Sebia HYDRASYS {Hydragel 15 Hb A1c} 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH April 25, 1997
10396 58224 Sigma Diagnostics Glycated Hemoglobin Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10397 58223 Sigma Diagnostics Glycohemoglobin Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10398 58210 Stanbio Premiere 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10399 58157 Stanbio Test Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10400 58230 Sterling Diagnostics Test Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
10401 K931183 61141 TECO Diagnostics Glycohemoglobin Kit 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH September 15, 1994
10410 4034 Abbott Beta-HCG 15/15 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10412 4147 Amersham Amerlex-M 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10413 4148 Amersham Amerlite 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10414 K981648 4824 Applied Biotech hCGColor hCG Test 2502 HCG, Beta, Serum, Quantitative 6 HIGH May 24, 1999
10422 7110 Becton Dickinson Solid Phase Coated Tube 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10426 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10427 7138 Bio-Rad CoTube 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10440 10061 Clinical Assays GammaDab 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10445 13030 Diagnostic Products Corp. Coat-A-Count 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10446 13109 Diagnostic Products Corp. Coat-A-Count IRMA 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10447 13031 Diagnostic Products Corp. Double Antibody 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10448 13111 Diagnostic Products Corp. Milenia 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10449 13226 Diamedix Serum HCG Microassay 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10453 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10454 25053 Hybritech Photon Immunoassay Analyzer 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10455 25022 Hybritech Tandem-E 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10456 25023 Hybritech Tandem-R 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10457 K952283 31016 Johnson & Johnson CDL Amerlite Analyzer 2502 HCG, Beta, Serum, Quantitative 6 HIGH August 18, 1995
10459 37026 Leeco Diagnostics Concept-7-Beta-hCG 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10460 37027 Leeco Diagnostics Concept-7-Beta-hCG IRMA 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10461 40117 Medix Biotech EIA Test Kit 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10462 43008 Nichols Institute Allegro RIA 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10463 43081 Nichols Institute Chemiluminescence HCG Assay 2502 HCG, Beta, Serum, Quantitative 6 HIGH September 1, 1994
10464 46007 Organon NML IRMA Test Kit 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10472 K941983 58340 SeaLite Sciences AquaLite hCG (manual curve) 2502 HCG, Beta, Serum, Quantitative 6 HIGH October 28, 1994
10474 58091 Serono Baker Serozyme 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10476 58251 Serono Diagnostics Serozyme 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10477 58047 Serono HCG MAIA Clone 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
10486 70147 Wallac Oy DELFIA hCG Kit 2502 HCG, Beta, Serum, Quantitative 6 HIGH September 1, 1994
10491 K960357 13419 Diagnostic Systems DSL 8300 ACTIVE INTACT hCG IRMA 2567 HCG, Intact, Serum, Quantitative 6 HIGH May 24, 1996
10492 K961911 13428 Diagnostic Systems DSL-10-8300 ACTIVE Intact hCG ELISA 2567 HCG, Intact, Serum, Quantitative 6 HIGH July 26, 1996
10519 13031 Diagnostic Products Corp. Double Antibody 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10520 13111 Diagnostic Products Corp. Milenia 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10533 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10534 25053 Hybritech Photon Immunoassay Analyzer 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10536 25022 Hybritech Tandem-E 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10541 37026 Leeco Diagnostics Concept-7-Beta-hCG 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10542 37027 Leeco Diagnostics Concept-7-Beta-hCG IRMA 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10553 43008 Nichols Institute Allegro RIA 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
10585 K991741 8209 BioCheck hCG EIA 2555 HCG, Total, Serum, Quantitative 6 HIGH August 12, 1999
10605 13031 Diagnostic Products Corp. Double Antibody 2503 HCG, Urine 6 HIGH July 26, 1993
10611 37026 Leeco Diagnostics Concept-7-Beta-hCG 2503 HCG, Urine 6 HIGH July 26, 1993
10612 37027 Leeco Diagnostics Concept-7-Beta-hCG IRMA 2503 HCG, Urine 6 HIGH July 26, 1993
10615 46007 Organon NML IRMA Test Kit 2503 HCG, Urine 6 HIGH July 26, 1993
10622 58091 Serono Baker Serozyme 2503 HCG, Urine 6 HIGH July 26, 1993
10623 58251 Serono Diagnostics Serozyme 2503 HCG, Urine 6 HIGH July 26, 1993
10631 K981648 4824 Applied Biotech hCGColor hCG Test 2534 HCG, Urine, Quantitative 6 HIGH May 24, 1999
10635 K952283 31016 Johnson & Johnson CDL Amerlite Analyzer 2534 HCG, Urine, Quantitative 6 HIGH August 18, 1995
10643 4035 Abbott Bichromatic ABA 100 2550 HDL Cholesterol 2 HIGH July 26, 1993
10644 4036 Abbott Bichromatic ABA 200 2550 HDL Cholesterol 2 HIGH July 26, 1993
10645 4067 Abbott Spectrum 2550 HDL Cholesterol 2 HIGH July 26, 1993
10655 4515 Abbott Spectrum CCX 2550 HDL Cholesterol 2 HIGH September 1, 1994
10657 4068 Abbott Spectrum EPX 2550 HDL Cholesterol 2 HIGH July 26, 1993
10665 4069 Abbott Spectrum Series II 2550 HDL Cholesterol 2 HIGH July 26, 1993
10672 4070 Abbott Spectrum Series II CCX 2550 HDL Cholesterol 2 HIGH July 26, 1993
10680 4082 Abbott VP 2550 HDL Cholesterol 2 HIGH July 26, 1993
10689 4139 American Monitor Diagnostics Excel 2550 HDL Cholesterol 2 HIGH July 26, 1993
10690 4140 American Monitor Diagnostics ISP 1000 2550 HDL Cholesterol 2 HIGH July 26, 1993
10691 4141 American Monitor Diagnostics ISP 2000 2550 HDL Cholesterol 2 HIGH July 26, 1993
10692 4143 American Monitor KDA 2550 HDL Cholesterol 2 HIGH July 26, 1993
10693 4144 American Monitor Parallel 2550 HDL Cholesterol 2 HIGH July 26, 1993
10694 4150 Ames Clinistat 2550 HDL Cholesterol 2 HIGH July 26, 1993
10695 7048 Baxter Paramax 2550 HDL Cholesterol 2 HIGH July 26, 1993
10700 7049 Baxter Paramax 720 ZX 2550 HDL Cholesterol 2 HIGH July 26, 1993
10707 7378 Beckman Manual Spectrophotometric Test Procedure 2550 HDL Cholesterol 2 HIGH July 26, 1993
10720 7174 Beckman Synchron CX 4 CE 2550 HDL Cholesterol 2 HIGH July 26, 1993
10726 K950958 7762 Beckman Synchron CX 4 DELTA 2550 HDL Cholesterol 2 HIGH April 19, 1996
10729 7072 Beckman Synchron CX 5 2550 HDL Cholesterol 2 HIGH July 26, 1993
10741 K926060 7491 Beckman Synchron CX 5 CE 2550 HDL Cholesterol 2 HIGH November 22, 1993
10747 K950958 7763 Beckman Synchron CX 5 DELTA 2550 HDL Cholesterol 2 HIGH April 19, 1996
10750 7073 Beckman Synchron CX 7 2550 HDL Cholesterol 2 HIGH July 26, 1993
10760 K950958 7764 Beckman Synchron CX 7 DELTA 2550 HDL Cholesterol 2 HIGH April 19, 1996
10765 K950958 7932 Beckman Synchron CX 9 ALX System 2550 HDL Cholesterol 2 HIGH September 12, 1997
10779 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2550 HDL Cholesterol 2 HIGH July 26, 1993
10791 7161 Boehringer Mannheim Hitachi 704 2550 HDL Cholesterol 2 HIGH July 26, 1993
10808 7163 Boehringer Mannheim Hitachi 717 2550 HDL Cholesterol 2 HIGH July 26, 1993
10821 7164 Boehringer Mannheim Hitachi 736 2550 HDL Cholesterol 2 HIGH July 26, 1993
10829 7165 Boehringer Mannheim Hitachi 737 2550 HDL Cholesterol 2 HIGH July 26, 1993
10850 7377 Boehringer Mannheim Hitachi 911 2550 HDL Cholesterol 2 HIGH July 26, 1993
10861 K942364 7546 Boehringer Mannheim Hitachi 914 2550 HDL Cholesterol 2 HIGH October 28, 1994
10864 K953239 7765 Boehringer Mannheim Hitachi 917 2550 HDL Cholesterol 2 HIGH March 22, 1996
10876 10352 Chiron Diagnostics 550 Express 2550 HDL Cholesterol 2 HIGH November 15, 1996
10890 10362 Chiron Diagnostics 580 Alliance 2550 HDL Cholesterol 2 HIGH November 15, 1996
10892 10359 Chiron Diagnostics Alliance 2550 HDL Cholesterol 2 HIGH November 15, 1996
10894 10038 Ciba Corning 550 Express 2550 HDL Cholesterol 2 HIGH July 26, 1993
10904 10039 Ciba Corning 570 Alliance 2550 HDL Cholesterol 2 HIGH July 26, 1993
10907 10040 Ciba Corning 580 Alliance 2550 HDL Cholesterol 2 HIGH July 26, 1993
10910 10106 Coulter Dacos 2550 HDL Cholesterol 2 HIGH July 26, 1993
10917 13216 DMA Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
10919 13517 Dade Behring Dimension AR 2550 HDL Cholesterol 2 HIGH September 18, 1998
10922 K944093 13519 Dade Behring Dimension RxL 2550 HDL Cholesterol 2 HIGH September 18, 1998
10924 13525 Dade Behring aca IV 2550 HDL Cholesterol 2 HIGH September 18, 1998
10927 K941050 13521 Dade Behring aca Star 2550 HDL Cholesterol 2 HIGH September 18, 1998
10930 13421 Dade Dimension AR 2550 HDL Cholesterol 2 HIGH July 12, 1996
10933 13420 Dade Dimension ES 2550 HDL Cholesterol 2 HIGH July 12, 1996
10935 K944093 13436 Dade Dimension RxL 2550 HDL Cholesterol 2 HIGH November 1, 1996
10938 K944093 13422 Dade Dimension XL 2550 HDL Cholesterol 2 HIGH July 12, 1996
10942 K941050 13423 Dade aca Star 2550 HDL Cholesterol 2 HIGH July 12, 1996
10943 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 2550 HDL Cholesterol 2 HIGH July 26, 1993
10944 13082 Du Pont ACA 2550 HDL Cholesterol 2 HIGH July 26, 1993
10948 13172 Du Pont ACA II 2550 HDL Cholesterol 2 HIGH July 26, 1993
10951 13173 Du Pont ACA III 2550 HDL Cholesterol 2 HIGH July 26, 1993
10954 13083 Du Pont ACA IV 2550 HDL Cholesterol 2 HIGH July 26, 1993
10957 K941050 13357 Du Pont ACA Star 2550 HDL Cholesterol 2 HIGH January 6, 1995
10958 13084 Du Pont ACA V 2550 HDL Cholesterol 2 HIGH July 26, 1993
10964 13086 Du Pont Dimension 2550 HDL Cholesterol 2 HIGH July 26, 1993
10969 13215 Du Pont Dimension ES 2550 HDL Cholesterol 2 HIGH July 26, 1993
10972 K944093 13355 Du Pont Dimension XL 2550 HDL Cholesterol 2 HIGH January 20, 1995
10974 16023 EM Diagnostic Systems EASY PLUS (manual pretreatment) 2550 HDL Cholesterol 2 HIGH July 26, 1993
10976 16024 EM Diagnostic Systems EASY ST (manual pretreatment) 2550 HDL Cholesterol 2 HIGH July 26, 1993
10977 16015 EM Diagnostic Systems EPOS 2550 HDL Cholesterol 2 HIGH July 26, 1993
10980 16010 Electronucleonics FLEXIGEM 2550 HDL Cholesterol 2 HIGH July 26, 1993
10998 K880176 25226 Horizon HDL Cholesterol (manual) 2550 HDL Cholesterol 2 HIGH April 28, 1995
10999 28160 Instrumentation Laboratory IL Genesis 21 2550 HDL Cholesterol 2 HIGH July 26, 1993
11004 28082 Instrumentation Laboratory IL Monarch 1000 2550 HDL Cholesterol 2 HIGH July 26, 1993
11009 28231 Instrumentation Laboratory IL Monarch 2000 2550 HDL Cholesterol 2 HIGH July 26, 1993
11025 28183 Instrumentation Laboratory Multistat III 2550 HDL Cholesterol 2 HIGH July 26, 1993
11026 28184 Instrumentation Laboratory Multistat III Plus 2550 HDL Cholesterol 2 HIGH July 26, 1993
11027 K934039 28321 Intersect Systems Test Kit 2550 HDL Cholesterol 2 HIGH May 20, 1994
11110 40126 Mallinckrodt Serometer 370 2550 HDL Cholesterol 2 HIGH July 26, 1993
11111 40123 Medical Analysis Systems Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11113 40118 Meditech Diagnostic System Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11114 K961274 46230 Olympus AU 1000 2550 HDL Cholesterol 2 HIGH February 14, 1997
11115 46001 Olympus AU 5000 2550 HDL Cholesterol 2 HIGH July 26, 1993
11123 46084 Olympus AU 5021 2550 HDL Cholesterol 2 HIGH July 26, 1993
11126 46085 Olympus AU 5031 2550 HDL Cholesterol 2 HIGH July 26, 1993
11129 46145 Olympus AU 5041 2550 HDL Cholesterol 2 HIGH September 1, 1994
11132 46086 Olympus AU 5061 2550 HDL Cholesterol 2 HIGH July 26, 1993
11136 46088 Olympus AU 5131 2550 HDL Cholesterol 2 HIGH July 26, 1993
11139 46143 Olympus AU 5200 2550 HDL Cholesterol 2 HIGH September 1, 1994
11147 46106 Olympus AU 5211 2550 HDL Cholesterol 2 HIGH July 26, 1993
11150 46107 Olympus AU 5221 2550 HDL Cholesterol 2 HIGH July 26, 1993
11153 46108 Olympus AU 5223 2550 HDL Cholesterol 2 HIGH July 26, 1993
11156 46109 Olympus AU 5231 2550 HDL Cholesterol 2 HIGH July 26, 1993
11161 46110 Olympus AU 800 2550 HDL Cholesterol 2 HIGH July 26, 1993
11176 46089 Olympus Reply 2550 HDL Cholesterol 2 HIGH July 26, 1993
11192 49064 Pointe Scientific 180 Chemistry Analyzer 2550 HDL Cholesterol 2 HIGH July 26, 1993
11195 55095 RDI Magnetic HDL Cholesterol (manual) 2550 HDL Cholesterol 2 HIGH July 26, 1993
11196 55075 Reagents Applications RAICHEM Test Kit (manual) 2550 HDL Cholesterol 2 HIGH July 26, 1993
11198 55100 Roche Diagnostics Cobas Bio 2550 HDL Cholesterol 2 HIGH July 26, 1993
11207 55040 Roche Diagnostics Cobas FARA 2550 HDL Cholesterol 2 HIGH July 26, 1993
11219 55041 Roche Diagnostics Cobas FARA II 2550 HDL Cholesterol 2 HIGH July 26, 1993
11229 55044 Roche Diagnostics Cobas Mira 2550 HDL Cholesterol 2 HIGH July 26, 1993
11246 55096 Roche Diagnostics Cobas Mira Plus 2550 HDL Cholesterol 2 HIGH July 26, 1993
11253 55045 Roche Diagnostics Cobas Mira S 2550 HDL Cholesterol 2 HIGH July 26, 1993
11261 55046 Roche Diagnostics Cobas Ready 2550 HDL Cholesterol 2 HIGH July 26, 1993
11262 55367 Roche Diagnostics Hitachi 704 2550 HDL Cholesterol 2 HIGH May 7, 1999
11289 55451 Roche Diagnostics Hitachi 736 2550 HDL Cholesterol 2 HIGH May 7, 1999
11298 55464 Roche Diagnostics Hitachi 737 2550 HDL Cholesterol 2 HIGH May 7, 1999
11308 55480 Roche Diagnostics Hitachi 747 2550 HDL Cholesterol 2 HIGH May 7, 1999
11323 55512 Roche Diagnostics Hitachi 911 2550 HDL Cholesterol 2 HIGH May 7, 1999
11335 K942364 55549 Roche Diagnostics Hitachi 914 2550 HDL Cholesterol 2 HIGH May 7, 1999
11339 K953239 55560 Roche Diagnostics Hitachi 917 2550 HDL Cholesterol 2 HIGH May 7, 1999
11355 K972015 58457 Sebia HYDRASYS {Hydragel (7,15/30) CHOL-HDL} 2550 HDL Cholesterol 2 HIGH October 31, 1997
11356 K972015 58456 Sebia Hydragel CHOL-HDL (manual) 2550 HDL Cholesterol 2 HIGH October 31, 1997
11357 58163 Seradyn HDL Cholesterol Determination 2550 HDL Cholesterol 2 HIGH July 26, 1993
11358 58187 Seradyn Quick-Chem II 2550 HDL Cholesterol 2 HIGH July 26, 1993
11359 58186 Seragen Quick-Chem 2550 HDL Cholesterol 2 HIGH July 26, 1993
11360 58185 Seragen StatEase 2550 HDL Cholesterol 2 HIGH July 26, 1993
11361 58165 Sherwood Medical Rapid Stat Diagnostic Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11362 K890023 58388 Sigma Diagnostics HDL ISOSPIN (manual) 2550 HDL Cholesterol 2 HIGH October 27, 1995
11363 58051 Sigma Diagnostics Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11364 58195 SmithKline ESKALAB-CCS 2550 HDL Cholesterol 2 HIGH July 26, 1993
11365 58210 Stanbio Premiere 2550 HDL Cholesterol 2 HIGH July 26, 1993
11366 58157 Stanbio Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11368 58229 Sterling Diagnostics Analyzer 2000 2550 HDL Cholesterol 2 HIGH July 26, 1993
11369 58260 Synermed Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11370 K880176 61429 TECO Diagnostics HDL-Cholesterol Reagent Set (manual) 2550 HDL Cholesterol 2 HIGH March 26, 1999
11371 K882938 61377 TECO Diagnostics TC 84 2550 HDL Cholesterol 2 HIGH November 19, 1998
11372 61049 TRACE HDL Singles (manual) 2550 HDL Cholesterol 2 HIGH July 26, 1993
11373 61001 Technicon AXON 2550 HDL Cholesterol 2 HIGH July 26, 1993
11377 61002 Technicon Assist 2550 HDL Cholesterol 2 HIGH July 26, 1993
11380 61003 Technicon Chem 1 2550 HDL Cholesterol 2 HIGH July 26, 1993
11383 61004 Technicon DAX 24 2550 HDL Cholesterol 2 HIGH July 26, 1993
11385 61005 Technicon DAX 48 2550 HDL Cholesterol 2 HIGH July 26, 1993
11388 61006 Technicon DAX 72 2550 HDL Cholesterol 2 HIGH July 26, 1993
11391 61007 Technicon DAX 96 2550 HDL Cholesterol 2 HIGH July 26, 1993
11394 61037 Technicon RA 100 2550 HDL Cholesterol 2 HIGH July 26, 1993
11397 61010 Technicon RA 1000 2550 HDL Cholesterol 2 HIGH July 26, 1993
11411 61012 Technicon RA 500 2550 HDL Cholesterol 2 HIGH July 26, 1993
11420 61013 Technicon RA XT 2550 HDL Cholesterol 2 HIGH July 26, 1993
11430 K943376 61161 Technicon opeRA 2550 HDL Cholesterol 2 HIGH November 10, 1994
11435 70103 Wako HDL Cholesterol Test Kit 2550 HDL Cholesterol 2 HIGH July 26, 1993
11438 P940004 46285 Oncor INFORM HER-2/neu Gene Detection System 2572 HER-2/neu Gene 2 HIGH July 31, 1998
11439 4334 Abbott COMMANDER System 2506 HIV Antibodies 3 HIGH July 26, 1993
11440 4053 Abbott HIVAB HIV-1 EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11441 4274 Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11442 7140 Bio-Rad Novapathe HIV-1 Immunoblot 2506 HIV Antibodies 3 HIGH July 26, 1993
11443 P920670 10481 Calypte HIV-1 Urine EIA 2506 HIV Antibodies 3 HIGH September 3, 1999
11444 10008 Cambridge Biotech HIV-1 WB 2506 HIV Antibodies 3 HIGH July 26, 1993
11446 10029 Cellular Products Retro-Tek HIV-1 ELISA 2506 HIV Antibodies 3 HIGH July 26, 1993
11447 13088 Du Pont HIV-1 ELISA 2506 HIV Antibodies 3 HIGH July 26, 1993
11448 16008 Electronucleonics HIV-1 IgG EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11449 22062 Genetic Systems HIV-1/HIV-2 EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11450 22063 Genetic Systems HIV-2 EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11451 22064 Genetic Systems LAV EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11453 46017 Organon Teknika Bio-EnzaBead HIV 2506 HIV Antibodies 3 HIGH July 26, 1993
11454 46028 Organon Teknika Epiblot HIV 2506 HIV Antibodies 3 HIGH July 26, 1993
11455 46036 Organon Teknika Vironostika HIV-1 Microelisa System 2506 HIV Antibodies 3 HIGH July 26, 1993
11456 46057 Ortho Diagnostics HIV-1 ELISA 2506 HIV Antibodies 3 HIGH July 26, 1993
11457 58087 Syva MicroTrak HIV-1 (env & gag) EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11458 64016 United Biomedical HIV-1 EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
11459 4054 Abbott HIVAG-1 2507 HIV Antigen 3 HIGH July 26, 1993
11460 B970017 8253 bioMerieux Vitek HLA-DR oligo-detection Kit 2576 HLA-DR 3 HIGH January 7, 2000
11461 4334 Abbott COMMANDER System 2508 HTLV Antibodies 3 HIGH July 26, 1993
11462 4055 Abbott HTLV-1 EIA 2508 HTLV Antibodies 3 HIGH July 26, 1993
11463 10146 Cambridge Biotech HTLV-1 ELISA 2508 HTLV Antibodies 3 HIGH July 26, 1993
11464 13089 Du Pont HTLV-1 ELISA 2508 HTLV Antibodies 3 HIGH July 26, 1993
11465 46113 Organon Teknika Vironstika HTLV-1 Microelisa Assay 2508 HTLV Antibodies 3 HIGH July 26, 1993
11466 K993679 13597 Dade Behring MicroScan MICroSTREP plus 2577 Haemophilus 8 HIGH January 26, 2000
11467 22040 Gen-Probe AccuProbe (including culture) 2542 Haemophilus influenzae 8 HIGH July 26, 1993
11468 13222 Difco Bacto H. influenzae Set (including culture) 2509 Haemophilus influenzae, type a, c-f 8 HIGH July 26, 1993
11469 13156 Difco FA H. influenzae Types A-F (direct Ag) 2509 Haemophilus influenzae, type a, c-f 8 HIGH July 26, 1993
11470 34005 Karobio Phadebact Haemophilus (including culture) 2509 Haemophilus influenzae, type a, c-f 8 HIGH July 26, 1993
11471 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11473 7261 Becton Dickinson Directigen Meningitis Indiv.Kit (blood culture supernatant) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11475 13222 Difco Bacto H. influenzae Set (including culture) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11476 13156 Difco FA H. influenzae Types A-F (direct Ag) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11478 34005 Karobio Phadebact Haemophilus (including culture) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11480 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11482 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 2510 Haemophilus influenzae, type b 8 HIGH July 26, 1993
11488 7383 Beckman Auto ICS 2511 Haptoglobin 2 HIGH July 26, 1993
11489 7381 Beckman ICS 2511 Haptoglobin 2 HIGH July 26, 1993
11490 7382 Beckman ICS II 2511 Haptoglobin 2 HIGH July 26, 1993
11502 7328 BioWhittaker FIAX System 2511 Haptoglobin 2 HIGH July 26, 1993
11510 25081 Helena Laboratories Haptoglobin 2511 Haptoglobin 2 HIGH July 26, 1993
11511 25024 Hycor Accuplate 2511 Haptoglobin 2 HIGH July 26, 1993
11518 28183 Instrumentation Laboratory Multistat III 2511 Haptoglobin 2 HIGH July 26, 1993
11519 28184 Instrumentation Laboratory Multistat III Plus 2511 Haptoglobin 2 HIGH July 26, 1993
11520 34001 Kallestad Endoplate RID 2511 Haptoglobin 2 HIGH July 26, 1993
11521 34003 Kallestad Quantiplate RID 2511 Haptoglobin 2 HIGH July 26, 1993
11526 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 2511 Haptoglobin 2 HIGH July 26, 1993
11553 61082 The Binding Site Human Haptoglobin RID 2511 Haptoglobin 2 HIGH July 26, 1993
11558 K980076 40311 Meridian Diagnostics Premier Platinum HpSA (spectrophotometric) 2512 Helicobacter pylori 8 HIGH October 30, 1998
11559 K980076 40310 Meridian Diagnostics Premier Platinum HpSA (visual) 2512 Helicobacter pylori 8 HIGH October 30, 1998
11562 K981396 4795 AMDL PyloriProbe ELISA 2513 Helicobacter pylori Antibodies 3 HIGH August 21, 1998
11566 K981396 4836 Alfa Scientific Designs Helicobacter pylori IgG ELISA 2513 Helicobacter pylori Antibodies 3 HIGH July 23, 1999
11571 7328 BioWhittaker FIAX System 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
11572 7340 BioWhittaker PYLORI STAT 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
11573 7245 Biomerica GAP-IgG ELISA 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
11579 K990462 13583 Diamedix Immunosimplicity (Is)-H. pylori IgG (manual) 2513 Helicobacter pylori Antibodies 3 HIGH November 19, 1999
11581 K944159 16076 Enteric Products HM-CAP EIA Test 2513 Helicobacter pylori Antibodies 3 HIGH July 28, 1995
11585 25049 Hycor PYLORAGEN H. pylori (IgG) Test Kit (serum) 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
11588 K982790 28553 INOVA Diagnostics QUANTA Lite H. Pylori IgG ELISA 2513 Helicobacter pylori Antibodies 3 HIGH April 2, 1999
11593 K973508 40297 Micro Detect PYLORI DETECT IgG 2513 Helicobacter pylori Antibodies 3 HIGH May 15, 1998
11594 K925190 43064 New Horizons Pylori Screen 2513 Helicobacter pylori Antibodies 3 HIGH November 22, 1993
11598 52012 Quidel Helicobacter pylori Microwell EIA Test 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
11606 K972981 58506 Shield Diagnostics Helico G2 2513 Helicobacter pylori Antibodies 3 HIGH May 15, 1998
11610 K924689 64025 United Biotech UBI MAGIWEL H. pylori IgG Test 2513 Helicobacter pylori Antibodies 3 HIGH November 22, 1993
11611 K961221 70198 Wampole H. Pylori IgG ELISA 2513 Helicobacter pylori Antibodies 3 HIGH July 18, 1997
11614 K980821 79064 Zeus Scientific Helicobactor pylori ELISA 2513 Helicobacter pylori Antibodies 3 HIGH January 22, 1999
11615 K953873 16112 elias usa Varelisa Helicobacter pyl. Abs (IgG) 2513 Helicobacter pylori Antibodies 3 HIGH September 13, 1996
11708 10127 Coulter ZBI6 2514 Hematocrit 4 HIGH July 26, 1993
11709 10129 Coulter ZF5 2514 Hematocrit 4 HIGH July 26, 1993
11710 13283 DMA H10 2514 Hematocrit 4 HIGH September 1, 1994
11712 13277 DMA H3-HCT 2514 Hematocrit 4 HIGH September 1, 1994
11713 13280 DMA H5 2514 Hematocrit 4 HIGH September 1, 1994
11714 13281 DMA H7 2514 Hematocrit 4 HIGH September 1, 1994
11751 40171 Mallinckrodt H5-M 2514 Hematocrit 4 HIGH September 1, 1994
11752 40169 Mallinckrodt S-610 2514 Hematocrit 4 HIGH September 1, 1994
11753 40173 Mallinckrodt S-670 2514 Hematocrit 4 HIGH September 1, 1994
11826 58305 SmithKline ESKALAB-CHS H10 2514 Hematocrit 4 HIGH September 1, 1994
11827 58300 SmithKline ESKALAB-CHS H3-HCT 2514 Hematocrit 4 HIGH September 1, 1994
11828 58303 SmithKline ESKALAB-CHS H5 2514 Hematocrit 4 HIGH September 1, 1994
11829 58304 SmithKline ESKALAB-CHS H7 2514 Hematocrit 4 HIGH September 1, 1994
11864 61127 Texas International Laboratories H10 2514 Hematocrit 4 HIGH September 1, 1994
11866 61121 Texas International Laboratories H3-HCT 2514 Hematocrit 4 HIGH September 1, 1994
11867 61124 Texas International Laboratories H5 2514 Hematocrit 4 HIGH September 1, 1994
11868 61123 Texas International Laboratories H5-M 2514 Hematocrit 4 HIGH September 1, 1994
11869 61125 Texas International Laboratories H7 2514 Hematocrit 4 HIGH September 1, 1994
11879 4035 Abbott Bichromatic ABA 100 2515 Hemoglobin 4 HIGH July 26, 1993
11999 10129 Coulter ZF5 2515 Hemoglobin 4 HIGH July 26, 1993
12000 13283 DMA H10 2515 Hemoglobin 4 HIGH September 1, 1994
12002 13278 DMA H3-Hgb 2515 Hemoglobin 4 HIGH September 1, 1994
12003 13280 DMA H5 2515 Hemoglobin 4 HIGH September 1, 1994
12004 13279 DMA H5-M 2515 Hemoglobin 4 HIGH September 1, 1994
12026 16010 Electronucleonics FLEXIGEM 2515 Hemoglobin 4 HIGH July 26, 1993
12045 40171 Mallinckrodt H5-M 2515 Hemoglobin 4 HIGH September 1, 1994
12046 40170 Mallinckrodt S-630 2515 Hemoglobin 4 HIGH September 1, 1994
12047 40172 Mallinckrodt S-650 2515 Hemoglobin 4 HIGH September 1, 1994
12048 40173 Mallinckrodt S-670 2515 Hemoglobin 4 HIGH September 1, 1994
12049 40126 Mallinckrodt Serometer 370 2515 Hemoglobin 4 HIGH July 26, 1993
12072 49064 Pointe Scientific 180 Chemistry Analyzer 2515 Hemoglobin 4 HIGH July 26, 1993
12113 58171 Seradyn Hemoglobin Determination 2515 Hemoglobin 4 HIGH July 26, 1993
12114 58187 Seradyn Quick-Chem II 2515 Hemoglobin 4 HIGH July 26, 1993
12117 58186 Seragen Quick-Chem 2515 Hemoglobin 4 HIGH July 26, 1993
12118 58185 Seragen StatEase 2515 Hemoglobin 4 HIGH July 26, 1993
12129 58051 Sigma Diagnostics Test Kit 2515 Hemoglobin 4 HIGH July 26, 1993
12130 58225 Sigma Diagnostics Total Hemoglobin 2515 Hemoglobin 4 HIGH July 26, 1993
12131 58195 SmithKline ESKALAB-CCS 2515 Hemoglobin 4 HIGH July 26, 1993
12132 58301 SmithKline ESKALAB-CHS H3-Hgb 2515 Hemoglobin 4 HIGH September 1, 1994
12133 58303 SmithKline ESKALAB-CHS H5 2515 Hemoglobin 4 HIGH September 1, 1994
12134 58302 SmithKline ESKALAB-CHS H5-M 2515 Hemoglobin 4 HIGH September 1, 1994
12135 58304 SmithKline ESKALAB-CHS H7 2515 Hemoglobin 4 HIGH September 1, 1994
12137 58210 Stanbio Premiere 2515 Hemoglobin 4 HIGH July 26, 1993
12139 58229 Sterling Diagnostics Analyzer 2000 2515 Hemoglobin 4 HIGH July 26, 1993
12172 K883683 61413 TECO Diagnostics Hemoglobin Reagent Set (manual) 2515 Hemoglobin 4 HIGH March 26, 1999
12173 K882938 61377 TECO Diagnostics TC 84 2515 Hemoglobin 4 HIGH November 19, 1998
12185 61127 Texas International Laboratories H10 2515 Hemoglobin 4 HIGH September 1, 1994
12187 61122 Texas International Laboratories H3-Hgb 2515 Hemoglobin 4 HIGH September 1, 1994
12188 61124 Texas International Laboratories H5 2515 Hemoglobin 4 HIGH September 1, 1994
12189 61123 Texas International Laboratories H5-M 2515 Hemoglobin 4 HIGH September 1, 1994
12190 61125 Texas International Laboratories H7 2515 Hemoglobin 4 HIGH September 1, 1994
12193 25116 Helena Laboratories Heme Spec Plus 2546 Hemoglobin A1 2 HIGH July 26, 1993
12198 25057 Helena Laboratories Beta-Thal HbA2 Quik Column 2535 Hemoglobin A2 2 HIGH July 26, 1993
12200 25116 Helena Laboratories Heme Spec Plus 2535 Hemoglobin A2 2 HIGH July 26, 1993
12201 25058 Helena Laboratories Sickle-Thal Quik Column 2535 Hemoglobin A2 2 HIGH July 26, 1993
12203 28101 Isolab Quik-Sep Alpha-Thal Screen 2537 Hemoglobin Barts 2 HIGH July 26, 1993
12204 K923153 28340 Isolab HemoCard Hemoglobin C 2559 Hemoglobin C 2 HIGH June 10, 1994
12205 K930070 28268 Isolab HemoCard Hemoglobin E 2556 Hemoglobin E 2 HIGH November 22, 1993
12207 25005 Helena Laboratories Quiplate System for RID 2516 Hemoglobin F 2 HIGH July 26, 1993
12208 28102 Isolab Quik-Sep Hemoglobin F Assay 2516 Hemoglobin F 2 HIGH July 26, 1993
12209 28103 Isolab Quik-Sep Sickle-Cell F Test 2516 Hemoglobin F 2 HIGH July 26, 1993
12213 7372 Beckman Paragon Acid Hemoglobin (Acid Hb) Electrophoresis Kit 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12219 25075 Helena Laboratories Hemoglobin Electrophoresis 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12220 K931465 25144 Helena Laboratories REP Alkaline Hb-15 2544 Hemoglobin Fractions 2 HIGH November 22, 1993
12221 25074 Helena Laboratories REP Hemoglobin-30 IEF Procedure 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12222 25076 Helena Laboratories Titan III Hgb ID Electrophoresis 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12223 25073 Helena Laboratories Titan IV Citrate Hgb Electrophoresis 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12224 28195 Isolab Resolve-Hb 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
12232 K924813 7498 Bio-Rad VARIANT 2536 Hemoglobin S 2 HIGH November 22, 1993
12235 25116 Helena Laboratories Heme Spec Plus 2536 Hemoglobin S 2 HIGH July 26, 1993
12237 28111 Isolab HemoCard Hemoglobin A and S 2536 Hemoglobin S 2 HIGH July 26, 1993
12238 28100 Isolab HemoCard Hemoglobin S 2536 Hemoglobin S 2 HIGH July 26, 1993
12239 K942276 28353 Isolab Quik-Sep Quantitative Hemoglobin S Assay 2536 Hemoglobin S 2 HIGH February 3, 1995
12253 K943516 4583 American Bioproducts ROTACHROM HBPM/LMWH 2518 Heparin 4 HIGH September 8, 1995
12254 K904297 4728 American Bioproducts ST4 BIO 2518 Heparin 4 HIGH June 20, 1997
12255 K961579 4677 American Bioproducts STA Compact Analyzer 2518 Heparin 4 HIGH November 1, 1996
12256 K983460 4875 American Bioproducts STA-R Analyzer 2518 Heparin 4 HIGH October 25, 1999
12257 K925433 4560 American Bioproducts STACHROM Heparin Assay 2518 Heparin 4 HIGH May 26, 1995
12258 K943517 4582 American Bioproducts STACLOT Heparin (manual) 2518 Heparin 4 HIGH May 19, 1995
12259 K925200 7481 Behring Berichrom Heparin (manual) 2518 Heparin 4 HIGH November 22, 1993
12260 7193 Bio/Data PAP-4C 2518 Heparin 4 HIGH July 26, 1993
12261 K972209 8022 Biopool Spectrolyse Heparin (anti-IIa) 2518 Heparin 4 HIGH January 9, 1998
12262 K952514 10313 Chromogenix COACUTE Heparin (manual) 2518 Heparin 4 HIGH December 1, 1995
12263 K983178 10500 Chromogenix COAMATIC Heparin (manual) 2518 Heparin 4 HIGH January 18, 2000
12264 K970431 13608 Dade Behring Coagulation System (BCS) 2518 Heparin 4 HIGH January 26, 2000
12265 K992423 13548 Dade Behring Sysmex CA-500 Series 2518 Heparin 4 HIGH January 18, 2000
12269 13218 Diagnostica Stago ST4 2518 Heparin 4 HIGH July 26, 1993
12270 13144 Diagnostica Stago Stachrom Heparin 2518 Heparin 4 HIGH July 26, 1993
12277 K952667 25238 Helena Laboratories Chrom Z-Heparin (manual) 2518 Heparin 4 HIGH January 27, 2000
12278 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 2518 Heparin 4 HIGH July 26, 1993
12279 K952667 25029 Helena Laboratories PACKS-4 2518 Heparin 4 HIGH January 27, 2000
12280 28075 Instrumentation Laboratory IL ACL 200 2518 Heparin 4 HIGH July 26, 1993
12281 28076 Instrumentation Laboratory IL ACL 2000 2518 Heparin 4 HIGH July 26, 1993
12282 28077 Instrumentation Laboratory IL ACL 300 2518 Heparin 4 HIGH July 26, 1993
12283 28079 Instrumentation Laboratory IL ACL 3000 Plus 2518 Heparin 4 HIGH July 26, 1993
12284 K961991 28454 Instrumentation Laboratory IL ACL 6000 2518 Heparin 4 HIGH September 13, 1996
12285 K961991 28487 Instrumentation Laboratory IL ACL 7000 2518 Heparin 4 HIGH September 19, 1997
12286 28183 Instrumentation Laboratory Multistat III 2518 Heparin 4 HIGH July 26, 1993
12287 28184 Instrumentation Laboratory Multistat III Plus 2518 Heparin 4 HIGH July 26, 1993
12288 37035 LAbor COA System 2518 Heparin 4 HIGH July 26, 1993
12289 K962664 40282 Medical Laboratory MLA Electra 1800C 2518 Heparin 4 HIGH December 5, 1997
12290 40042 Medical Laboratory MLA Electra 900C 2518 Heparin 4 HIGH July 26, 1993
12291 46091 Organon Teknika Chromostrate Heparin Anti-Xa Assay 2518 Heparin 4 HIGH July 26, 1993
12292 K965076 46144 Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 2518 Heparin 4 HIGH February 20, 1998
12293 K992130 49231 Pacific Hemostasis ThromboScreen 400C 2518 Heparin 4 HIGH January 28, 2000
12294 K992321 58606 Sysmex CA-6000 2518 Heparin 4 HIGH January 27, 2000
12295 K992321 61283 TOA Medical Electronics CA-6000 2518 Heparin 4 HIGH January 18, 2000
12296 K934274 67095 Vitek HEMOLAB Heparichrom 2518 Heparin 4 HIGH January 6, 1995
12299 28093 ITC Factor VI 2539 Heparin Dose Response (HDR) 4 HIGH September 1, 1994
12300 28094 ITC HEMOCHRON 400 2539 Heparin Dose Response (HDR) 4 HIGH September 1, 1994
12301 28095 ITC HEMOCHRON 401 2539 Heparin Dose Response (HDR) 4 HIGH September 1, 1994
12302 28096 ITC HEMOCHRON 800 2539 Heparin Dose Response (HDR) 4 HIGH September 1, 1994
12304 28097 ITC HEMOCHRON 801 2539 Heparin Dose Response (HDR) 4 HIGH September 1, 1994
12306 K983475 28603 ITC HEMOCHRON Response (manual dosage calculations) 2539 Heparin Dose Response (HDR) 4 HIGH January 31, 2000
12308 K961579 4677 American Bioproducts STA Compact Analyzer 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH November 1, 1996
12309 K983460 4875 American Bioproducts STA-R Analyzer 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH October 25, 1999
12310 K952667 25238 Helena Laboratories Chrom Z-Heparin (manual) 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH January 27, 2000
12311 K952667 25029 Helena Laboratories PACKS-4 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH January 27, 2000
12312 K935212 28341 Instrumentation Laboratory IL Test Heparin (Xa) 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH June 10, 1994
12313 K965076 46144 Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 2558 Heparin, Low Molecular Weight (LMWH) 4 HIGH February 20, 1998
12317 28093 ITC Factor VI 2538 Heparin/Protamine Titration (HPT) 4 HIGH September 1, 1994
12318 28094 ITC HEMOCHRON 400 2538 Heparin/Protamine Titration (HPT) 4 HIGH September 1, 1994
12319 28095 ITC HEMOCHRON 401 2538 Heparin/Protamine Titration (HPT) 4 HIGH September 1, 1994
12320 28096 ITC HEMOCHRON 800 2538 Heparin/Protamine Titration (HPT) 4 HIGH September 1, 1994
12321 28097 ITC HEMOCHRON 801 2538 Heparin/Protamine Titration (HPT) 4 HIGH September 1, 1994
12322 K983475 28578 ITC HEMOCHRON Response 2538 Heparin/Protamine Titration (HPT) 4 HIGH January 31, 2000
12323 4001 ADI Heprofile Anti-HAV IgM EIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12324 4334 Abbott COMMANDER System 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12325 4046 Abbott HAVAB EIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12326 4047 Abbott HAVAB RIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12327 4048 Abbott HAVAB-M EIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12328 4049 Abbott HAVAB-M RIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12330 46031 Organon Teknika Hepanostika Anti-HAV Microelisa Total Ab. 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12331 58055 Sorin Biomedica AB-HAVK 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12332 58252 Sorin Biomedica ETI AB-HAVK 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12333 58063 Sorin Biomedica HA-IgMK IRMA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12334 58142 Syva MicroTrak II Total Anti-HAV EIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12335 58155 Syva MicroTrak Total Anti-HAV EIA 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
12337 4334 Abbott COMMANDER System 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12338 4040 Abbott CORAB 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12339 4041 Abbott CORAB-M 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12340 4042 Abbott CORZYME 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12341 4369 Abbott CORZYME-M (r-DNA) 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12342 22059 Genetic Systems Anti-HBc EIA 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12343 46029 Organon Teknika Hepanostika ANTICORE Microelisa System 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12344 58054 Sorin Biomedica AB-COREK, AB-COREK J 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12345 58060 Sorin Biomedica ETI-AB-COREK EIA 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12346 58156 Syva MicroTrak IgM Anti-HBcore EIA 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
12347 4269 ADI Heprofile Anti-HBs 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12348 4024 Abbott AUSAB EIA 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12349 4025 Abbott AUSAB RIA 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12350 4334 Abbott COMMANDER System 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12351 46034 Organon Teknika Microplate Anti-HBs EIA 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12352 58053 Sorin Biomedica AB-AUK-3 RIA 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
12353 4270 ADI Heprofile HBsAg 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12354 4268 ADI Heprofile HBsAg Specificity Test Kit 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12355 4027 Abbott AUSCELL (RPHA) 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12356 4028 Abbott AUSCELL Confirmatory Test (RPHA) 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12357 4029 Abbott AUSRIA RIA 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12358 4031 Abbott AUSZYME Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12359 4030 Abbott AUSZYME MONOCLONAL EIA 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12360 4334 Abbott COMMANDER System 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12362 C900566 4658 Abbott IMX HBsAg Confirmatory 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH April 19, 1996
12363 22060 Genetic Systems HBsAg Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12364 22061 Genetic Systems HBsAg EIA 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12365 46005 Organon NML ELISA HBsAg Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12366 46006 Organon NML ELISA HBsAg Screening Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12367 46010 Organon NML RIA HBsAg Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12368 46011 Organon NML RIA HBsAg Screening Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12369 46041 Ortho Antibody to HBsAg ELISA Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12370 46042 Ortho Antibody to HBsAg ELISA Test System II 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12371 49007 Pharmacia Hepatitis B Surface Antigen Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12372 49008 Pharmacia Hepatitis B Surface Antigen-AntiHBs ELISA 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12373 58056 Sorin Biomedica AUK-3, AUK 3J RIA 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12374 58058 Sorin Biomedica Confirmatory Test 2524 Hepatitis B Surface Antigen (HBsAg) 3 HIGH July 26, 1993
12375 4334 Abbott COMMANDER System 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12376 4050 Abbott HBe (rDNA) EIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12377 46032 Organon Teknika Hepanostika HBeAg/Anti-HBe Microelisa 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12378 58059 Sorin Biomedica EBK RIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12379 58061 Sorin Biomedica ETI-EBK EIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12380 58154 Syva MicroTrak HBeAg/Anti-HBe EIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12381 58144 Syva MicroTrak II Anti-HBe EIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
12383 4334 Abbott COMMANDER System 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12384 4050 Abbott HBe (rDNA) EIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12385 4051 Abbott HBe RIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12386 46032 Organon Teknika Hepanostika HBeAg/Anti-HBe Microelisa 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12387 58059 Sorin Biomedica EBK RIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12388 58061 Sorin Biomedica ETI-EBK EIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12389 58154 Syva MicroTrak HBeAg/Anti-HBe EIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12390 58143 Syva MicroTrak II HBeAg EIA 2526 Hepatitis Be Antigen 3 HIGH July 26, 1993
12392 4052 Abbott HCV-EIA 2527 Hepatitis C Virus Antibody 3 HIGH July 26, 1993
12394 46071 Ortho HCV ELISA 2527 Hepatitis C Virus Antibody 3 HIGH July 26, 1993
12395 4032 Abbott Anti-delta-EIA 2528 Hepatitis delta Antibody 3 HIGH July 26, 1993
12396 4033 Abbott Anti-delta-RIA 2528 Hepatitis delta Antibody 3 HIGH July 26, 1993
12397 7031 Baxter Bartels HSV FA Monoclonal (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12398 7032 Baxter Bartels HSV FA-ID & Diff. HSV I/II (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12399 7198 Baxter Bartels HSV Immunoperoxidase Test (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12400 K871877 13332 DAKO IDEIA Herpes simplex (direct Ag) 2529 Herpes simplex 10 HIGH March 3, 1995
12401 K870602 13333 DAKO IMAGEN Herpes simplex (including cell culture) 2529 Herpes simplex 10 HIGH March 3, 1995
12402 K960578 13435 Diagnostic Hybrids ELVIS HSV GOLD (including cell culture) 2529 Herpes simplex 10 HIGH October 25, 1996
12403 K971662 13481 Diagnostic Hybrids ELVIS HSV ID/Typing (including cell culture) 2529 Herpes simplex 10 HIGH March 27, 1998
12404 K941924 13318 Diagnostic Hybrids ELVIS HSV Kit (including cell culture) 2529 Herpes simplex 10 HIGH May 5, 1995
12405 13220 Diagnostic Products Corp. PDx Herpes Typing (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12406 13124 Du Pont HERPCHEK HSV Antigen Test (direct Ag/spectrophotometric) 2529 Herpes simplex 10 HIGH July 26, 1993
12407 19010 Fairleigh Dickinson ELISA for HSV (direct Ag/spectrophotometric) 2529 Herpes simplex 10 HIGH July 26, 1993
12408 19001 Fairleigh Dickinson ELISA for HSV (direct Ag/visual) 2529 Herpes simplex 10 HIGH July 26, 1993
12409 19012 Fairleigh Dickinson ELISA for HSV (including cell culture/spectrophotometric) 2529 Herpes simplex 10 HIGH July 26, 1993
12410 19009 Fairleigh Dickinson ELISA for HSV (including cell culture/visual) 2529 Herpes simplex 10 HIGH July 26, 1993
12411 K902661 28592 INTRACEL Bartels HSV 1 & 2 FA Typing (including cell culture) 2529 Herpes simplex 10 HIGH January 18, 2000
12412 K902662 28593 INTRACEL Bartels HSV FA Bivalent DFA (including cell culture) 2529 Herpes simplex 10 HIGH January 18, 2000
12413 K842830 28594 INTRACEL Bartels HSV Immunoperoxidase Test (including cell culture) 2529 Herpes simplex 10 HIGH January 18, 2000
12415 K884680 31064 Johnson & Johnson CDI SureCell (including cell culture) 2529 Herpes simplex 10 HIGH October 6, 1995
12417 34019 Kodak SureCell (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12418 K991880 37159 Light Diagnostics SimulFluor HSV 1/2 IFA (direct antigen) 2529 Herpes simplex 10 HIGH January 26, 2000
12419 K991880 37160 Light Diagnostics SimulFluor HSV 1/2 IFA (including culture) 2529 Herpes simplex 10 HIGH January 26, 2000
12420 K990141 37161 Light Diagnostics SimulFluor HSV/VZV IFA (direct antigen) 2529 Herpes simplex 10 HIGH January 26, 2000
12421 K990141 37162 Light Diagnostics SimulFluor HSV/VZV IFA (including culture) 2529 Herpes simplex 10 HIGH January 26, 2000
12422 K953839 40238 Meridian Diagnostics Premier HSV Plus (direct Ag/spectrophotometric) 2529 Herpes simplex 10 HIGH May 31, 1996
12423 K953839 40239 Meridian Diagnostics Premier HSV Plus (direct antigen/visual) 2529 Herpes simplex 10 HIGH May 31, 1996
12424 K953839 40237 Meridian Diagnostics Premier HSV Plus (including cell culture/spectrophotometric) 2529 Herpes simplex 10 HIGH May 31, 1996
12425 K953839 40236 Meridian Diagnostics Premier HSV Plus (including cell culture/visual) 2529 Herpes simplex 10 HIGH May 31, 1996
12426 46056 Ortho Cultureset HSV Isolation and ID System (direct Ag) 2529 Herpes simplex 10 HIGH July 26, 1993
12427 46072 Ortho HSV 1 & 2 Dichromatic Typing (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12428 46104 Ortho HSV Antigen ELISA Test (direct Ag/spectrophotometric) 2529 Herpes simplex 10 HIGH July 26, 1993
12429 58004 Sanofi/Kallestad Pathfinder H. simplex 1&2 (direct Ag) 2529 Herpes simplex 10 HIGH July 26, 1993
12430 58095 Syva MicroTrak HSV Culture Identification Test (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12431 58088 Syva MicroTrak HSV-1/2 Culture ID/Typing (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12432 58096 Syva MicroTrak HSV-1/HSV-2 Direct Spec ID/Typ Test (direct Ag) 2529 Herpes simplex 10 HIGH July 26, 1993
12434 67040 Vitek Systems Vidas (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12436 70017 Wampole Virogen Herpes LA Test (including cell culture) 2529 Herpes simplex 10 HIGH July 26, 1993
12437 4343 Analytab ACCU-LYZA HSV-1 and HSV-2 ELISA Test System 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12438 K922584 7506 Baxter Bartels Herpes simplex-1 Virus IgG PRIMA System EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 22, 1993
12439 K922334 7505 Baxter Bartels Herpes simplex-1 Virus IgM PRIMA System EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 22, 1993
12440 K922583 7508 Baxter Bartels Herpes simplex-2 Virus IgG PRIMA System EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 22, 1993
12441 K922333 7507 Baxter Bartels Herpes simplex-2 Virus IgM PRIMA System EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 22, 1993
12442 7288 Baxter Bartels PRIMA HSV 1 IgG EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12443 7289 Baxter Bartels PRIMA HSV 1 IgM EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12444 7287 Baxter Bartels PRIMA HSV 2 IgG EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12445 7328 BioWhittaker FIAX System 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12446 7329 BioWhittaker HERPELISA II 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12447 7330 BioWhittaker HERPES 1&2 STAT 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12448 7331 BioWhittaker HERPES STAT 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12449 7157 Bion HSV1-G or HSV2-G Test System 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12453 13049 Diagnostic Technology HSV Check 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12454 13242 Diamedix Herpes 1 & 2 Microassay 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12455 K981306 13502 Diamedix Immunosimplicity (Is)-HSV 1 & 2 IgG (manual) 2530 Herpes simplex I and/or II Antibodies 3 HIGH October 2, 1998
12458 22214 GenBio Herpes simplex Virus IgG IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH August 1, 1997
12459 22215 GenBio Herpes simplex Virus IgM IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH August 1, 1997
12462 22146 General Biometrics Herpes simplex Virus IgG IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12463 22147 General Biometrics Herpes simplex Virus IgM IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12467 K830865 22084 Gull Laboratories HSV IgM IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12468 K910954 22085 Gull Laboratories HSV-1 IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12469 K922758 22086 Gull Laboratories HSV-1 IgM ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12470 K910952 22087 Gull Laboratories HSV-2 IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12471 K922759 22088 Gull Laboratories HSV-2 IgM ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12472 K983541 22259 Gull Laboratories Herpes Simplex Virus 1&2 IgG ELISA (manual/qualitative) 2530 Herpes simplex I and/or II Antibodies 3 HIGH April 16, 1999
12473 28221 Incstar Clin-ELISA Herpes simplex Type-1 IgG 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12474 28222 Incstar Clin-ELISA Herpes simplex Type-2 IgG 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12475 28042 Incstar Fluoro-Kit 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12476 K955363 28459 Incstar HSV I/II IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 8, 1996
12480 46073 Ortho Herpes simplex virus Antibodies Fluoroset 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12481 49024 Pharmacia Herpes simplex Virus, Type 1 IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12482 49023 Pharmacia Herpes simplex Virus, Type 2 IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12483 K963282 52049 Quest International SeraQuest HSV IgG (manual/qualitative) 2530 Herpes simplex I and/or II Antibodies 3 HIGH February 14, 1997
12484 K963282 52050 Quest International SeraQuest HSV IgG (manual/semi-quantitative) 2530 Herpes simplex I and/or II Antibodies 3 HIGH February 14, 1997
12486 K963282 52051 Quest International SeraQuest HSV IgG {Hyperion HyPrep Plus} (manual calculations) 2530 Herpes simplex I and/or II Antibodies 3 HIGH February 14, 1997
12491 58196 Sigma Diagnostics SIA Herpes 1 and Herpes 2 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12492 67022 Virgo Herpes Simplex Virus Type 1 Antibody IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12493 67023 Virgo Herpes Simplex Virus Type 2 Antibody IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12494 K963645 70210 Wampole Herpes Group IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH January 23, 1998
12495 79009 Zeus Scientific HSV Antibody 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12496 79010 Zeus Scientific HSV-1 and HSV-2 IgG ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
12499 7256 Biomerica RIA Test Kit 2541 Histamine 7 HIGH July 26, 1993
12500 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2563 Histidine 2 HIGH November 10, 1994
12501 28030 Immuno-Mycologics ID-Histo Antibody System 2531 Histoplasma Antibodies 3 HIGH July 26, 1993
12503 40134 Meridian Diagnostics Premier Histoplasma EIA 2531 Histoplasma Antibodies 3 HIGH July 26, 1993
12504 22135 Gen-Probe AccuProbe - H. capsulatum (including culture) 2532 Histoplasma capsulatum 12 HIGH July 26, 1993
12505 28198 Immuno-Mycologics Exo-Antigen Test Kit (including culture) 2532 Histoplasma capsulatum 12 HIGH July 26, 1993
12507 K980907 4828 Axis Homocysteine EIA 2574 Homocysteine 2 HIGH June 11, 1999
12508 K993107 7792 Bio-Rad CDM System {Bio-Rad HPLC} 2574 Homocysteine 2 HIGH January 7, 2000
12509 K982003 13593 Drew Scientific DS30 Analyzer {DS30 Hcy Homocysteine Assay} 2574 Homocysteine 2 HIGH November 19, 1999
12510 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2561 Homocystine 2 HIGH November 10, 1994
12511 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 2545 Homovanillic Acid (HVA) 6 HIGH August 23, 1996
12512 7279 Bio-Rad HPLC 2545 Homovanillic Acid (HVA) 6 HIGH July 26, 1993
12513 K934977 16043 esa Coulochem Electrode Array System (CEAS) 2545 Homovanillic Acid (HVA) 6 HIGH June 10, 1994
12514 K972873 58539 Scimedx ImmuSTRIP HAMA IgG ELISA 2573 Human Anti-Mouse Antibodies (HAMA) 3 HIGH October 30, 1998
12515 K973203 58574 Sangstat ThymoStat ELISA 2575 Human Anti-Rabbit Antibodies 3 HIGH May 24, 1999
12516 E990038 4859 Alfa Scientific Designs Human Growth Hormone (HGH) EIA 2547 Human Growth Hormone (GH) 6 HIGH July 23, 1999
12519 13031 Diagnostic Products Corp. Double Antibody 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
12520 K960551 13415 Diagnostic Systems DSL 10-1900 ACTIVE hGH ELISA 2547 Human Growth Hormone (GH) 6 HIGH April 12, 1996
12521 K970701 13460 Diagnostic Systems DSL-1900 ACTIVE Human Growth Hormone IRMA 2547 Human Growth Hormone (GH) 6 HIGH July 25, 1997
12522 25023 Hybritech Tandem-R 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
12523 E990026 34098 KMI Diagnostics hGH ELISA 2547 Human Growth Hormone (GH) 6 HIGH March 26, 1999
12524 E990025 34097 KMI Diagnostics hGH-IRMA 2547 Human Growth Hormone (GH) 6 HIGH March 26, 1999
12525 34040 Kallestad Quantitope HGH RIA Kit 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
12527 43008 Nichols Institute Allegro RIA 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
12528 43068 Nichols Institute Chemiluminescence HGH Assay 2547 Human Growth Hormone (GH) 6 HIGH September 1, 1994
12529 K972761 58463 SeaLite Sciences AquaLite hGH (computer calculations) 2547 Human Growth Hormone (GH) 6 HIGH October 10, 1997
12536 K930484 70162 Wallac Oy DELFIA hGH Kit 2547 Human Growth Hormone (GH) 6 HIGH November 22, 1993
12537 K874482 58403 SmithKline HemeSelect 2565 Human Hemoglobin in Feces 2 HIGH April 5, 1996
12538 13121 Digene ViraPap (direct Ag) 2540 Human Papillomavirus (HPV) 10 HIGH July 26, 1993
12539 13122 Digene ViraType (direct Ag) 2540 Human Papillomavirus (HPV) 10 HIGH July 26, 1993
12540 K890064 13323 Digene ViraType Plus HPV DNA Assay 2540 Human Papillomavirus (HPV) 10 HIGH November 23, 1994
12543 13030 Diagnostic Products Corp. Coat-A-Count 2533 Human Placental Lactogen (hPL) 6 HIGH July 26, 1993
12544 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2562 Hydroxylysine 2 HIGH November 10, 1994
12545 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2560 Hydroxyproline 2 HIGH November 10, 1994
12546 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 2560 Hydroxyproline 2 HIGH May 26, 1995
12547 13243 Diamedix Circulating Immune Complexes 2801 Immune complexes (CIC) 3 HIGH July 26, 1993
12548 52004 Quidel CIC-C1q EIA 2801 Immune complexes (CIC) 3 HIGH July 26, 1993
12549 58197 Sigma Diagnostics SIA Immune Complexes 2801 Immune complexes (CIC) 3 HIGH July 26, 1993
12551 25133 Helena Laboratories REP ImmunoFix 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH September 1, 1994
12552 25008 Helena Laboratories Titan Gel ImmunoFix 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH July 26, 1993
12553 25060 Helena Laboratories Titan Gel ImmunoFix Plus 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH July 26, 1993
12554 25009 Helena Laboratories Titan Gel Immunoelectrophoresis 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH July 26, 1993
12555 K931247 25149 Helena Laboratories Titan Gel Immunofix-9 Procedure 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH November 22, 1993
12556 25061 Helena Laboratories Titan IV Immunoelectrophoresis 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH July 26, 1993
12557 K973040 25288 Helena laboratories SPIFE Immunofix-6 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH March 6, 1998
12558 34002 Kallestad Immunoelectrophoresis System 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH July 26, 1993
12559 K972591 58525 Sebia HYDRASYS {Hydragel 2/4 Bence Jones} 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH September 11, 1998
12560 K972591 58526 Sebia Hydragel Bence Jones (manual) 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH September 11, 1998
12561 K924767 61117 The Binding Site IFE and Zone Electrophoresis Kit 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH November 22, 1993
12562 K924769 61115 The Binding Site Immunofixation IFE 2802 Immunoglobulins - monoclonal/polyclonal 3 HIGH November 22, 1993
12570 7383 Beckman Auto ICS 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12571 7381 Beckman ICS 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12572 7382 Beckman ICS II 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12588 7119 Behring Nor-partigen Kit 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12590 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12591 7328 BioWhittaker FIAX System 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12602 K933971 10258 Crestat Diagnostics N-Assay TIA IgA (manual) 2803 Immunoglobulins IgA 3 HIGH September 30, 1994
12614 25055 Helena Laboratories Low Level Quiplate System for RID 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12615 25005 Helena Laboratories Quiplate System for RID 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12616 25024 Hycor Accuplate 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12622 28184 Instrumentation Laboratory Multistat III Plus 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12623 34036 Kallestad Endoplate Low Level Immunoglobulin Test Kit 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12624 34001 Kallestad Endoplate RID 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12625 34003 Kallestad Quantiplate RID 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12626 34010 Kent Radial Immunodiffusion Test 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12632 K955794 55203 Randox Laboratories IgA (manual) 2803 Immunoglobulins IgA 3 HIGH May 10, 1996
12633 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12653 61067 The Binding Site Human Immunoglobulin G,A,M Polyclonal RID 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
12656 K931806 61111 The Binding Site Human IgA Subclasses NL RID 2827 Immunoglobulins IgA subclasses 3 HIGH November 22, 1993
12657 25005 Helena Laboratories Quiplate System for RID 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12658 25024 Hycor Accuplate 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12659 34001 Kallestad Endoplate RID 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12660 34003 Kallestad Quantiplate RID 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12661 34010 Kent Radial Immunodiffusion Test 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12662 61076 The Binding Site Human Immunoglobulin D RID 2804 Immunoglobulins IgD 3 HIGH July 26, 1993
12663 4005 ALerCHEK FlipSCREEN Total IgE 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12665 4472 Abbott IgE EIA 2805 Immunoglobulins IgE 3 HIGH September 1, 1994
12673 K992528 8231 BioCheck Immunoglobulin E (IgE) ELISA 2805 Immunoglobulins IgE 3 HIGH November 1, 1999
12674 7318 BioWhittaker 3M Total IgE II FAST Test 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12675 7328 BioWhittaker FIAX System 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12681 10055 Ciba Corning Magic Lite 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12687 13207 Dexall Biomedical AllergE ActiTip System 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12688 13027 Diagnostic Products Corp. AlaSTAT Total IgE 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12689 K935488 13293 Diagnostic Products Corp. AlaTOP Microplate Allergy Screen 2805 Immunoglobulins IgE 3 HIGH June 10, 1994
12690 13109 Diagnostic Products Corp. Coat-A-Count IRMA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12691 13111 Diagnostic Products Corp. Milenia 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12692 25023 Hybritech Tandem-R 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12694 K940183 25161 Hycor HY-TEC Total IgE EIA (manual) 2805 Immunoglobulins IgE 3 HIGH September 15, 1994
12695 25315 Hycor Total IgE RIA 2805 Immunoglobulins IgE 3 HIGH January 26, 2000
12696 28173 Immunotech EZ-BEAD EIA Kit 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12702 34042 Kallestad Allercoat EAST 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12703 34043 Kallestad Allercoat RAST 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12704 34032 Kallestad QuantiCLONE 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12705 34033 Kallestad Quantizyme IgE 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12706 37008 Leeco Diagnostics IgE Quant 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12707 40176 MAST CLA Allergy System (densitometer) 2805 Immunoglobulins IgE 3 HIGH May 15, 1995
12708 40112 MAST CLA Allergy Systems (chemiluminescence) 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12709 40177 MAST CLA-1 Chemiluminescent Allergy System 2805 Immunoglobulins IgE 3 HIGH May 15, 1995
12711 40102 Medix Biotech IgE Enzyme Immunoassay Test 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12712 43009 Nichols Institute Allegro IgE 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12713 49049 Pharmacia CAP System IgE RIA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12714 49032 Pharmacia IgE EIA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12715 49035 Pharmacia IgE EIA Ultra 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12716 49033 Pharmacia IgE RIA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12717 49036 Pharmacia IgE RIA Ultra 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12718 49034 Pharmacia IgE RIACT 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12719 49040 Pharmacia Phadebas IgE PRIST 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12720 49039 Pharmacia Phadezym IgE PRIST 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12725 K930890 55120 Roche Diagnostics Cobas Core IgE Total EIA (manual) 2805 Immunoglobulins IgE 3 HIGH January 21, 1994
12730 58231 Sanofi/Kallestad Total IgE Microplate 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12731 58091 Serono Baker Serozyme 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12732 58251 Serono Diagnostics Serozyme 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12736 K920087 61105 The Binding Site IgE EIA 2805 Immunoglobulins IgE 3 HIGH November 22, 1993
12738 67060 Ventrex PD IgE RIA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12739 67058 Ventrex Total IgE EIA Extended Range 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12740 67061 Ventrex Total IgE RIA Extended Range 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
12742 70163 Wallac Oy DELFIA Total IgE Kit 2805 Immunoglobulins IgE 3 HIGH September 1, 1994
12749 4275 Ames OPTIMATE 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12753 7383 Beckman Auto ICS 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12754 7381 Beckman ICS 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12755 7382 Beckman ICS II 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12769 7119 Behring Nor-partigen Kit 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12771 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12772 7328 BioWhittaker FIAX System 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12796 25055 Helena Laboratories Low Level Quiplate System for RID 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12797 25056 Helena Laboratories Quiplate RID Mid-Level IgG 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12798 25005 Helena Laboratories Quiplate System for RID 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12799 25024 Hycor Accuplate 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12804 28183 Instrumentation Laboratory Multistat III 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12805 28184 Instrumentation Laboratory Multistat III Plus 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12806 34036 Kallestad Endoplate Low Level Immunoglobulin Test Kit 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12807 34001 Kallestad Endoplate RID 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12808 34034 Kallestad Endoplate Ultra Low Level IgG Test Kit 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12809 34003 Kallestad Quantiplate RID 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12810 34010 Kent Radial Immunodiffusion Test 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12814 K955798 55205 Randox Laboratories IgG (manual) 2806 Immunoglobulins IgG 3 HIGH May 10, 1996
12815 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12838 61067 The Binding Site Human Immunoglobulin G,A,M Polyclonal RID 2806 Immunoglobulins IgG 3 HIGH July 26, 1993
12841 K982023 8142 Beckman Array {Inova Diagnostics Peliclass human IgG subclass} (manual curve) 2807 Immunoglobulins IgG subclasses 3 HIGH November 19, 1998
12843 K940422 7921 Beckman Array {The Binding Site IgG Subclasses} (manual curve) 2807 Immunoglobulins IgG subclasses 3 HIGH June 20, 1997
12846 31001 Janssen Biochemica IgG subclasses ELISA Kit 2807 Immunoglobulins IgG subclasses 3 HIGH July 26, 1993
12847 K943205 55151 Research Diagnostics Human IgG Subclass RID Combi Kit 2807 Immunoglobulins IgG subclasses 3 HIGH February 3, 1995
12848 K943098 55138 Research Diagnostics IgG Subclass ELISA Combi Kit 2807 Immunoglobulins IgG subclasses 3 HIGH November 10, 1994
12852 61084 The Binding Site BINDAZYME Human IgG Subclasses EIA 2807 Immunoglobulins IgG subclasses 3 HIGH July 26, 1993
12853 61070 The Binding Site Human IgG Subclasses Monoclonal RID 2807 Immunoglobulins IgG subclasses 3 HIGH July 26, 1993
12854 61071 The Binding Site Human IgG Subclasses Single Dilution RID 2807 Immunoglobulins IgG subclasses 3 HIGH July 26, 1993
12864 4275 Ames OPTIMATE 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12866 7381 Beckman ICS 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12867 7382 Beckman ICS II 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12883 7119 Behring Nor-partigen Kit 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12884 7246 Behring S-partigen Kit 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12886 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12887 7328 BioWhittaker FIAX System 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12898 K933970 10259 Crestat Diagnostics N-Assay TIA IgM (manual) 2808 Immunoglobulins IgM 3 HIGH September 30, 1994
12909 25055 Helena Laboratories Low Level Quiplate System for RID 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12910 25024 Hycor Accuplate 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12916 28183 Instrumentation Laboratory Multistat III 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12917 28184 Instrumentation Laboratory Multistat III Plus 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12918 34035 Kallestad Endoplate Low Level IgM Test Kit 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12919 34001 Kallestad Endoplate RID 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12920 34003 Kallestad Quantiplate RID 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12921 34010 Kent Radial Immunodiffusion Test 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12927 K955797 55204 Randox Laboratories IgM (manual) 2808 Immunoglobulins IgM 3 HIGH May 10, 1996
12928 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
12949 61067 The Binding Site Human Immunoglobulin G,A,M Polyclonal RID 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
13023 4215 Analytab API IMAGEN Influenza Virus A&B (direct Ag) 2828 Influenza A 10 HIGH September 30, 1994
13024 4512 Analytab API IMAGEN Influenza Virus A&B (including cell culture) 2828 Influenza A 10 HIGH September 30, 1994
13025 K924006 7490 Baxter Bartels PRIMA Influenza A EIA (direct Ag/spectrophotometric) 2828 Influenza A 10 HIGH November 22, 1993
13026 K924006 7492 Baxter Bartels PRIMA Influenza A EIA (including cell culture) 2828 Influenza A 10 HIGH November 22, 1993
13027 7035 Baxter Bartels Viral Respiratory Kit (direct Ag) 2828 Influenza A 10 HIGH September 1, 1994
13028 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 2828 Influenza A 10 HIGH September 1, 1994
13031 K872958 13336 DAKO IMAGEN Influenza (direct Ag) 2828 Influenza A 10 HIGH March 3, 1995
13032 K872958 13337 DAKO IMAGEN Influenza (including cell culture) 2828 Influenza A 10 HIGH March 3, 1995
13033 K913351 22106 Gull Laboratories Influenza A Test (including cell culture) 2828 Influenza A 10 HIGH September 1, 1994
13034 K924006 28595 INTRACEL Bartels PRIMA Influenza A EIA (direct Ag/spectrophotometric) 2828 Influenza A 10 HIGH January 18, 2000
13035 28599 INTRACEL Bartels Viral Respiratory Kit (direct Ag) 2828 Influenza A 10 HIGH January 18, 2000
13036 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 2828 Influenza A 10 HIGH January 18, 2000
13037 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 2828 Influenza A 10 HIGH November 22, 1993
13038 K974302 37144 Light Diagnostics SimulFluor Flu A/Flu B (direct Ag) 2828 Influenza A 10 HIGH July 17, 1998
13039 K974302 37145 Light Diagnostics SimulFluor Flu A/Flu B (including culture) 2828 Influenza A 10 HIGH July 17, 1998
13040 K942172 43093 NeoGenex Influenza A Antigen Test (including cell culture) 2828 Influenza A 10 HIGH September 15, 1994
13041 K984596 79066 ZymeTx ViraSTAT FITC-Labeled Anti-Influenza Types A and B (including cell culture) 2828 Influenza A 10 HIGH March 26, 1999
13042 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 2828 Influenza A 10 HIGH June 21, 1996
13043 7313 Bio-Medical Virotech ELISA Antibody Test 2810 Influenza A Antibodies 3 HIGH July 26, 1993
13046 K984596 79066 ZymeTx ViraSTAT FITC-Labeled Anti-Influenza Types A and B (including cell culture) 2835 Influenza A/B 10 HIGH March 26, 1999
13048 4215 Analytab API IMAGEN Influenza Virus A&B (direct Ag) 2829 Influenza B 10 HIGH September 30, 1994
13049 4512 Analytab API IMAGEN Influenza Virus A&B (including cell culture) 2829 Influenza B 10 HIGH September 30, 1994
13050 7035 Baxter Bartels Viral Respiratory Kit (direct Ag) 2829 Influenza B 10 HIGH September 1, 1994
13051 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 2829 Influenza B 10 HIGH September 1, 1994
13052 K872958 13336 DAKO IMAGEN Influenza (direct Ag) 2829 Influenza B 10 HIGH March 3, 1995
13053 K872958 13337 DAKO IMAGEN Influenza (including cell culture) 2829 Influenza B 10 HIGH March 3, 1995
13054 K913214 22107 Gull Laboratories Influenza B Test (including cell culture) 2829 Influenza B 10 HIGH September 1, 1994
13055 28599 INTRACEL Bartels Viral Respiratory Kit (direct Ag) 2829 Influenza B 10 HIGH January 18, 2000
13056 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 2829 Influenza B 10 HIGH January 18, 2000
13057 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 2829 Influenza B 10 HIGH November 22, 1993
13058 K974302 37144 Light Diagnostics SimulFluor Flu A/Flu B (direct Ag) 2829 Influenza B 10 HIGH July 17, 1998
13059 K974302 37145 Light Diagnostics SimulFluor Flu A/Flu B (including culture) 2829 Influenza B 10 HIGH July 17, 1998
13060 K942174 43096 NeoGenex Influenza B Antigen Test (including cell culture) 2829 Influenza B 10 HIGH September 15, 1994
13061 K984596 79066 ZymeTx ViraSTAT FITC-Labeled Anti-Influenza Types A and B (including cell culture) 2829 Influenza B 10 HIGH March 26, 1999
13062 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 2829 Influenza B 10 HIGH June 21, 1996
13063 7313 Bio-Medical Virotech ELISA Antibody Test 2811 Influenza B Antibodies 3 HIGH July 26, 1993
13064 K963911 4679 ALPCO Mercodia Insulin ELISA 2812 Insulin 6 HIGH November 22, 1996
13068 10051 Ciba Corning Magic (MGC) 2812 Insulin 6 HIGH July 26, 1993
13069 13030 Diagnostic Products Corp. Coat-A-Count 2812 Insulin 6 HIGH July 26, 1993
13070 13197 Diagnostic Systems Insulin RIA Kit 2812 Insulin 6 HIGH July 26, 1993
13071 28045 Incstar Insulin 2812 Insulin 6 HIGH July 26, 1993
13072 40085 Micromedic Systems CONCEPT 4 2812 Insulin 6 HIGH July 26, 1993
13073 40111 Micromedic Systems Concept 4 Plus 2812 Insulin 6 HIGH July 26, 1993
13074 49009 Pharmacia Insulin Test 2812 Insulin 6 HIGH July 26, 1993
13082 K951752 13381 Diagnostic Systems Active IGF-1 ELISA 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH May 19, 1995
13083 13181 Diagnostic Systems Active Insulin-Like Growth Factor-1 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH July 26, 1993
13084 K961172 13418 Diagnostic Systems DSL 2800 ACTIVE No-extrac.IGF-1 C-T IRMA 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH May 10, 1996
13085 K971353 13465 Diagnostic Systems DSL-10-2800 ACTIVE Non-Extraction IGF-1 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH August 1, 1997
13086 K950510 28385 ImmunoDiagnostic Systems OCTEIA IGF-1 IEMA Kit 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH April 21, 1995
13087 28206 Incstar IGF-I (Somatomedin C) 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH July 26, 1993
13089 K952505 43106 Nichols Institute Insulin-Like Growth Factor I (IGF-I) IRMA 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH July 14, 1995
13090 43044 Nichols Institute RIA Kit 2818 Insulin-like Growth Factor-1 (IGF-1) 6 HIGH July 26, 1993
13091 K962758 13431 Diagnostic Systems DSL-9100 ACTIVE IGF-II IRMA 2834 Insulin-like Growth Factor-II (IGF-II) 6 HIGH October 4, 1996
13092 K951707 13382 Diagnostic Systems Active IGFBP-3 ELISA 2832 Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) 6 HIGH May 19, 1995
13093 K950228 13375 Diagnostic Systems Active IGFBP-3 IRMA Kit 2832 Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) 6 HIGH March 10, 1995
13094 K930047 13310 Diagnostic Systems DSL-6700 IGFBP-3 RIA Kit 2832 Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) 6 HIGH September 15, 1994
13095 K921868 16060 Endocrine Sciences IGFBP-3 RIA Kit 2832 Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) 6 HIGH June 10, 1994
13096 K946247 43104 Nichols Institute IGFBP-3 Radioimmunoassay Kit 2832 Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) 6 HIGH June 30, 1995
13097 61119 T Cell Diagnostics CELLFREE Interleukin-2 Receptor Kit 2821 Interleukin-2 Receptor (IL-2R) 3 HIGH September 1, 1994
13098 4263 All Concentrated Preparations 2813 Intestinal parasites 11 HIGH July 26, 1993
13099 4262 All Wet Mount Preparations (identification of parasites) 2813 Intestinal parasites 11 HIGH July 26, 1993
13103 4035 Abbott Bichromatic ABA 100 2814 Iron 2 HIGH July 26, 1993
13116 4143 American Monitor KDA 2814 Iron 2 HIGH July 26, 1993
13117 4144 American Monitor Parallel 2814 Iron 2 HIGH July 26, 1993
13157 13213 DataChem DC-100 2814 Iron 2 HIGH July 26, 1993
13158 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 2814 Iron 2 HIGH July 26, 1993
13168 16010 Electronucleonics FLEXIGEM 2814 Iron 2 HIGH July 26, 1993
13173 K901561 25224 Horizon Iron/IBC (manual) 2814 Iron 2 HIGH April 28, 1995
13181 28183 Instrumentation Laboratory Multistat III 2814 Iron 2 HIGH July 26, 1993
13182 28184 Instrumentation Laboratory Multistat III Plus 2814 Iron 2 HIGH July 26, 1993
13228 49064 Pointe Scientific 180 Chemistry Analyzer 2814 Iron 2 HIGH July 26, 1993
13230 55075 Reagents Applications RAICHEM Test Kit (manual) 2814 Iron 2 HIGH July 26, 1993
13250 58185 Seragen StatEase 2814 Iron 2 HIGH July 26, 1993
13251 58051 Sigma Diagnostics Test Kit 2814 Iron 2 HIGH July 26, 1993
13252 58210 Stanbio Premiere 2814 Iron 2 HIGH July 26, 1993
13253 58229 Sterling Diagnostics Analyzer 2000 2814 Iron 2 HIGH July 26, 1993
13254 K901561 61423 TECO Diagnostics Iron/TIBC Reagent Set (manual) 2814 Iron 2 HIGH March 26, 1999
13255 61044 TRACE Scientific Test Kit 2814 Iron 2 HIGH July 26, 1993
13266 61016 Technicon SMAC 2814 Iron 2 HIGH July 26, 1993
13267 61045 Technicon SMAC 2 2814 Iron 2 HIGH July 26, 1993
13268 61046 Technicon SMAC 3 2814 Iron 2 HIGH July 26, 1993
13272 70099 Wako Fe B Test Kit 2814 Iron 2 HIGH July 26, 1993
13273 70118 Wako Fe C Test Kit 2814 Iron 2 HIGH July 26, 1993
13274 K981279 4797 Abbott ALCYON 300/300i Analyzer 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH October 2, 1998
13275 K981654 4798 Abbott Aeroset 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH October 9, 1998
13276 4067 Abbott Spectrum 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13277 4515 Abbott Spectrum CCX 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13278 4068 Abbott Spectrum EPX 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13279 4069 Abbott Spectrum Series II 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13280 4070 Abbott Spectrum Series II CCX 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13281 4071 Abbott TDX 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13282 4072 Abbott TDX FLx 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13283 4082 Abbott VP 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13284 4139 American Monitor Diagnostics Excel 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13285 4140 American Monitor Diagnostics ISP 1000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13286 4141 American Monitor Diagnostics ISP 2000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13287 4143 American Monitor KDA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13288 4144 American Monitor Parallel 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13289 7048 Baxter Paramax 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13290 7049 Baxter Paramax 720 ZX 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13291 7071 Beckman Synchron CX 4 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13292 7174 Beckman Synchron CX 4 CE 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13293 7072 Beckman Synchron CX 5 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13294 K926060 7491 Beckman Synchron CX 5 CE 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH November 22, 1993
13295 K950958 7763 Beckman Synchron CX 5 DELTA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH April 19, 1996
13296 7073 Beckman Synchron CX 7 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13297 K950958 7764 Beckman Synchron CX 7 DELTA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH April 19, 1996
13298 K950958 7932 Beckman Synchron CX 9 ALX System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 12, 1997
13299 K950958 8076 Beckman Synchron LX System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH April 10, 1998
13300 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13301 7189 Bio-Chem Laboratory Systems ATAC 6000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13302 7161 Boehringer Mannheim Hitachi 704 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13303 7162 Boehringer Mannheim Hitachi 705 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13304 7163 Boehringer Mannheim Hitachi 717 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13305 7164 Boehringer Mannheim Hitachi 736 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13306 7165 Boehringer Mannheim Hitachi 737 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13307 7166 Boehringer Mannheim Hitachi 747 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13308 7377 Boehringer Mannheim Hitachi 911 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13309 K942364 7546 Boehringer Mannheim Hitachi 914 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH October 28, 1994
13310 K953239 7765 Boehringer Mannheim Hitachi 917 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH April 5, 1996
13311 10352 Chiron Diagnostics 550 Express 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH November 15, 1996
13312 10038 Ciba Corning 550 Express 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13313 10106 Coulter Dacos 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13314 10115 Coulter Optichem 100 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13315 10079 Coulter Optichem 120 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13316 10080 Coulter Optichem 180 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13317 13517 Dade Behring Dimension AR 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 18, 1998
13318 K944093 13519 Dade Behring Dimension RxL 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 18, 1998
13319 13525 Dade Behring aca IV 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 18, 1998
13320 K941050 13521 Dade Behring aca Star 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 18, 1998
13321 13421 Dade Dimension AR 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 12, 1996
13322 13420 Dade Dimension ES 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 12, 1996
13323 K944093 13436 Dade Dimension RxL 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH November 1, 1996
13324 K944093 13422 Dade Dimension XL 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 12, 1996
13325 13213 DataChem DC-100 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13326 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13327 13082 Du Pont ACA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13328 13172 Du Pont ACA II 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13329 13173 Du Pont ACA III 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13330 13083 Du Pont ACA IV 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13331 K941050 13357 Du Pont ACA Star 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH January 6, 1995
13332 13084 Du Pont ACA V 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13333 13086 Du Pont Dimension 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13334 13087 Du Pont Dimension AR 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13335 13215 Du Pont Dimension ES 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13336 K944093 13355 Du Pont Dimension XL 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH January 20, 1995
13337 16015 EM Diagnostic Systems EPOS 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13338 16010 Electronucleonics FLEXIGEM 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13339 16004 Electronucleonics Gem-Profiler 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13340 16005 Electronucleonics Gemini 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13341 16006 Electronucleonics Gemstar 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13342 16007 Electronucleonics Gemstar II 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13343 28160 Instrumentation Laboratory IL Genesis 21 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13344 28082 Instrumentation Laboratory IL Monarch 1000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13345 28231 Instrumentation Laboratory IL Monarch 2000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13346 28083 Instrumentation Laboratory IL Monarch Plus 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13347 28183 Instrumentation Laboratory Multistat III 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13348 28184 Instrumentation Laboratory Multistat III Plus 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13349 K922072 31019 Johnson & Johnson CDI Ektachem 250 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13350 K811919 31020 Johnson & Johnson CDI Ektachem 400 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13351 K890928 31021 Johnson & Johnson CDI Ektachem 500 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13352 K890928 31022 Johnson & Johnson CDI Ektachem 550 XRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13353 K833833 31023 Johnson & Johnson CDI Ektachem 700 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13354 K890929 31024 Johnson & Johnson CDI Ektachem 700 C Series 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13355 K872105 31026 Johnson & Johnson CDI Ektachem 700 XR 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13356 K890929 31027 Johnson & Johnson CDI Ektachem 750 XRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13357 K946090 31028 Johnson & Johnson CDI Ektachem 950 IRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 29, 1995
13358 K922072 31068 Johnson & Johnson Vitros 250 Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13359 K890928 31069 Johnson & Johnson Vitros 500 Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13360 K890928 31070 Johnson & Johnson Vitros 550 Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13361 K833833 31071 Johnson & Johnson Vitros 700 Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13362 K890929 31072 Johnson & Johnson Vitros 750 XRC Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13363 K946090 31073 Johnson & Johnson Vitros 950 IRC Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH March 28, 1997
13364 34050 Kenlor Industries Test Kit 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13365 K933329 34051 King Diagnostics Test Kit 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 20, 1994
13366 34037 Kodak Ektachem 250 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13367 34012 Kodak Ektachem 400 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13368 34013 Kodak Ektachem 500 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13369 34014 Kodak Ektachem 700 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13370 34054 Kodak Ektachem 700 C Series 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13371 34015 Kodak Ektachem 700 XR 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13372 34055 Kodak Ektachem 750 XRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13373 K946090 34087 Kodak Ektachem 950 IRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 17, 1995
13374 37069 LSI ASCA Chemistry System 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13375 46001 Olympus AU 5000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13376 46084 Olympus AU 5021 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13377 46085 Olympus AU 5031 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13378 46145 Olympus AU 5041 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13379 46086 Olympus AU 5061 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13380 46087 Olympus AU 5121 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13381 46088 Olympus AU 5131 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13382 46143 Olympus AU 5200 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
13383 46106 Olympus AU 5211 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13384 46107 Olympus AU 5221 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13385 46108 Olympus AU 5223 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13386 46109 Olympus AU 5231 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13387 46110 Olympus AU 800 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13388 46002 Olympus Demand 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13389 46089 Olympus Reply 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13390 46129 Olympus Reply/AU 560 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13391 K922072 46271 Ortho-Clinical Diagnostics Vitros 250 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13392 K890928 46272 Ortho-Clinical Diagnostics Vitros 500 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13393 K890928 46273 Ortho-Clinical Diagnostics Vitros 550 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13394 K833833 46274 Ortho-Clinical Diagnostics Vitros 700 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13395 K890929 46275 Ortho-Clinical Diagnostics Vitros 750 XRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13396 K946090 46276 Ortho-Clinical Diagnostics Vitros 950 IRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH February 20, 1998
13397 49064 Pointe Scientific 180 Chemistry Analyzer 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13398 55075 Reagents Applications RAICHEM Test Kit (manual) 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13399 55100 Roche Diagnostics Cobas Bio 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13400 55040 Roche Diagnostics Cobas FARA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13401 55041 Roche Diagnostics Cobas FARA II 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13402 55044 Roche Diagnostics Cobas Mira 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13403 55096 Roche Diagnostics Cobas Mira Plus 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13404 55367 Roche Diagnostics Hitachi 704 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13405 55401 Roche Diagnostics Hitachi 717 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13406 55451 Roche Diagnostics Hitachi 736 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13407 55464 Roche Diagnostics Hitachi 737 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13408 55480 Roche Diagnostics Hitachi 747 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13409 K921661 55598 Roche Diagnostics Hitachi 902 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 24, 1999
13410 55512 Roche Diagnostics Hitachi 911 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13411 K942364 55549 Roche Diagnostics Hitachi 914 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
13412 58051 Sigma Diagnostics Test Kit 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13413 58210 Stanbio Premiere 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13414 58157 Stanbio Test Kit 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13415 61003 Technicon Chem 1 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13416 61004 Technicon DAX 24 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13417 61005 Technicon DAX 48 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13418 61006 Technicon DAX 72 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13419 61007 Technicon DAX 96 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13420 61010 Technicon RA 1000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13421 61011 Technicon RA 2000 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13422 61012 Technicon RA 500 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13423 61013 Technicon RA XT 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13424 70099 Wako Fe B Test Kit 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
13458 K901561 25224 Horizon Iron/IBC (manual) 2823 Iron Binding Capacity, Unsat. (UIBC) no pretreat. 2 HIGH April 28, 1995
13471 K864819 55075 Reagents Applications RAICHEM Test Kit (manual) 2823 Iron Binding Capacity, Unsat. (UIBC) no pretreat. 2 HIGH January 26, 1996
13488 K932517 58051 Sigma Diagnostics Test Kit 2823 Iron Binding Capacity, Unsat. (UIBC) no pretreat. 2 HIGH May 25, 1994
13489 K901561 61423 TECO Diagnostics Iron/TIBC Reagent Set (manual) 2823 Iron Binding Capacity, Unsat. (UIBC) no pretreat. 2 HIGH March 26, 1999
13496 70119 Wako UIBC Test Kit 2823 Iron Binding Capacity, Unsat. (UIBC) no pretreat. 2 HIGH July 26, 1993
13501 58051 Sigma Diagnostics Test Kit 2820 Isocitric Dehydrogenase 2 HIGH July 26, 1993
13502 4113 All Isohemagglt. Tube Titrations, Serum Pretreatment-Thiol 2816 Isohemagglutinins 5 HIGH July 26, 1993
13504 13017 Dade Neutr-AB Reagent - screen 2816 Isohemagglutinins 5 HIGH July 26, 1993
13505 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2833 Isoleucine 2 HIGH November 10, 1994
13506 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 2833 Isoleucine 2 HIGH May 26, 1995
13511 4275 Ames OPTIMATE 3401 Kanamycin 7 HIGH July 26, 1993
13514 7383 Beckman Auto ICS 3402 Kappa Light Chains 3 HIGH July 26, 1993
13515 7381 Beckman ICS 3402 Kappa Light Chains 3 HIGH July 26, 1993
13516 7382 Beckman ICS II 3402 Kappa Light Chains 3 HIGH July 26, 1993
13530 K964063 4757 Abbott Bichromatic ABA 100 {DMA One Shots} 3748 LDL Cholesterol 2 HIGH December 12, 1997
13531 K964064 4758 Abbott Bichromatic ABA 100 {RDI LipiDirect Magnetic LDL} 3748 LDL Cholesterol 2 HIGH December 19, 1997
13546 K964063 4755 Abbott VP {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13548 K964063 4753 Abbott VP {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13550 K964064 4762 Abbott VP {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13552 K943150 4615 Abbott Vision {Genzyme immunoseparation tube} (HDL channel) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13639 K964063 10419 Coulter Optichem {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13640 K964063 10416 Coulter Optichem {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13642 K964064 10422 Coulter Optichem {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13648 K964063 13470 Dade Dimension {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13649 K964063 13468 Dade Dimension {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13651 K964064 13472 Dade Dimension {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13660 K943150 13379 Du Pont Dimension {Genzyme immunoseparation tube} (HDL channel) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13662 K943150 13380 Du Pont Dimension AR {Genzyme immunoseparation tube} (HDL channel) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13665 K964063 16170 EM Diagnostic Systems EPOS {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13668 K964064 16178 EM Diagnostic Systems EPOS {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13672 K964063 16164 Electronucleonics Gemini {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13673 K964063 16156 Electronucleonics Gemini {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13675 K964064 16172 Electronucleonics Gemini {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13678 K964063 16166 Electronucleonics Gemprofiler {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13679 K964063 16158 Electronucleonics Gemprofiler {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13681 K964064 16174 Electronucleonics Gemprofiler {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13684 K964063 16168 Electronucleonics Gemstar {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13686 K964063 16160 Electronucleonics Gemstar {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13688 K964064 16176 Electronucleonics Gemstar {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13690 K964064 28506 Instrumentation Laboratory IL Gen.21 {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13692 K964063 28502 Instrumentation Laboratory IL Genesis 21 {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13693 K964063 28497 Instrumentation Laboratory IL Genesis 21 {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13698 K964063 28500 Instrumentation Laboratory IL Monarch {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13699 K964063 28495 Instrumentation Laboratory IL Monarch {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13701 K964064 28504 Instrumentation Laboratory IL Monarch {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13709 K943150 31036 Johnson & Johnson CDI Ektachem 250 {Genzyme tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH September 29, 1995
13710 K943150 31043 Johnson & Johnson CDI Ektachem 500 {Genzyme tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH September 29, 1995
13711 K943150 31048 Johnson & Johnson CDI Ektachem 700 {Genzyme tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH September 29, 1995
13712 K943150 31058 Johnson & Johnson CDI Ektachem DT 60 {Genzyme tube} (HDL slide) 3748 LDL Cholesterol 2 HIGH September 29, 1995
13715 K964063 31079 Johnson & Johnson Vitros {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13716 K964063 31077 Johnson & Johnson Vitros {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13718 K964064 31081 Johnson & Johnson Vitros {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13721 K943150 34089 Kodak Ektachem 250 {Genzyme immunoseparation tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13722 K943150 34090 Kodak Ektachem 500 {Genzyme immunoseparation tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13723 K943150 34092 Kodak Ektachem DT 60 {Genzyme immunoseparation tube} (HDL slide) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13742 K964063 46257 Olympus Demand {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13744 K964063 46253 Olympus Demand {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13746 K964064 46263 Olympus Demand {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13749 K964063 46259 Olympus Reply {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13751 K964063 46255 Olympus Reply {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13752 K964064 46265 Olympus Reply {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13756 K964063 46281 Ortho-Clinical Diagnostics Vitros {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH February 20, 1998
13757 K964063 46270 Ortho-Clinical Diagnostics Vitros {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH February 20, 1998
13761 K964063 55261 RDI LDL Cholesterol Precipitating Reagent (manual) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13762 K964064 55271 RDI LipiDirect Magnetic LDL (manual) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13764 K964063 55267 Roche Diagnostics Cobas Bio {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13766 K964063 55263 Roche Diagnostics Cobas Bio {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13768 K964064 55273 Roche Diagnostics Cobas Bio {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13771 K964063 55269 Roche Diagnostics Cobas FARA {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13773 K964063 55265 Roche Diagnostics Cobas FARA {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13775 K964064 55275 Roche Diagnostics Cobas FARA {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13845 K964063 58476 Schiapparelli Biosystems ACE {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13847 K964063 58474 Schiapparelli Biosystems ACE {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13849 K964064 58478 Schiapparelli Biosystems ACE {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13854 K964063 61328 Technicon Assist {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13856 K964063 61314 Technicon Assist {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13858 K964064 61342 Technicon Assist {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13860 K943150 61194 Technicon Chem 1 {Genzyme immunoseparation tube} (HDL channel) 3748 LDL Cholesterol 2 HIGH April 21, 1995
13872 K964063 61326 Technicon RA 100 {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13873 K964063 61312 Technicon RA 100 {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13875 K964064 61340 Technicon RA 100 {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13878 K964063 61322 Technicon RA 1000 {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13880 K964063 61308 Technicon RA 1000 {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13886 K964063 61318 Technicon RA 2000 {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13887 K964063 61304 Technicon RA 2000 {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13889 K964064 61332 Technicon RA 2000 {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13892 K964063 61324 Technicon RA 500 {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13895 K964064 61338 Technicon RA 500 {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13899 K964063 61320 Technicon RA XT {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13901 K964063 61306 Technicon RA XT {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13903 K964064 61334 Technicon RA XT {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13907 K964063 61316 Technicon opeRA {DMA One Shots} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 12, 1997
13908 K964063 61302 Technicon opeRA {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
13910 K964064 61330 Technicon opeRA {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
13917 4035 Abbott Bichromatic ABA 100 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13918 4036 Abbott Bichromatic ABA 200 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13919 4267 Abbott Bichromatic ABA 50 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13931 4143 American Monitor KDA 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13932 4144 American Monitor Parallel 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13934 4275 Ames OPTIMATE 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
13987 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14000 16010 Electronucleonics FLEXIGEM 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14006 K946022 25183 HiChem LDH/L Reagent Kit (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH March 3, 1995
14007 K880842 25217 Horizon Lactate Dehydrogenase (LDH) (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH April 28, 1995
14041 40126 Mallinckrodt Serometer 370 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14042 K952747 40217 MeDiTech Lactate Dehydrogenase (LD) (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH August 18, 1995
14043 40124 Medical Analysis Systems RefLab Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14044 40123 Medical Analysis Systems Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14045 40118 Meditech Diagnostic System Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14069 49064 Pointe Scientific 180 Chemistry Analyzer 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14071 55075 Reagents Applications RAICHEM Test Kit (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14095 58162 Seradyn LDH-UV Determination 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14096 58185 Seragen StatEase 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14097 58051 Sigma Diagnostics Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14098 58195 SmithKline ESKALAB-CCS 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14099 58210 Stanbio Premiere 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14100 58229 Sterling Diagnostics Analyzer 2000 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14103 K874848 61415 TECO Diagnostics LDH-L Reagent Set (manual) 3701 Lactate Dehydrogenase (LDH) 2 HIGH March 26, 1999
14104 K882938 61377 TECO Diagnostics TC 84 3701 Lactate Dehydrogenase (LDH) 2 HIGH November 19, 1998
14105 61044 TRACE Scientific Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14117 61014 Technicon SMA 12/60 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14118 61016 Technicon SMAC 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14119 61045 Technicon SMAC 2 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14120 61046 Technicon SMAC 3 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14122 70102 Wako Autokit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14125 70114 Wako Lactate Dehydrogenase CII Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
14127 4035 Abbott Bichromatic ABA 100 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
14128 4036 Abbott Bichromatic ABA 200 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
14148 13216 DMA Test Kit 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
14186 58158 Seradyn LD-1 Separation Set 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
14187 58051 Sigma Diagnostics Test Kit 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
14193 7365 Beckman Paragon LD Isoenzyme Electrophoresis Kit 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14194 K940224 25169 Helena Laboratories Cardio REP LD Isoenzyme Procedure 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH October 14, 1994
14195 25083 Helena Laboratories LDH Isoenzyme Electrophoresis 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14196 25100 Helena Laboratories REP CK/LD Isoenzyme Combo Method 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14197 25085 Helena Laboratories REP LD Isoenzyme Procedure 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14198 25086 Helena Laboratories REP LD Stat Isoenzyme Procedure 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14199 25092 Helena Laboratories Titan Gel Iso-Dot LD Flur (black) 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14200 25095 Helena Laboratories Titan Gel LD Isoenzyme Procedure 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14201 25108 Helena Laboratories Titan Gel-PC LD Isoenzyme Procedure 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
14202 K970477 58436 Sebia HYDRASYS {Hydragel 15 ISO-LDH} 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH March 14, 1997
14203 K970477 58435 Sebia Hydragel ISO-LDH (manual) 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH March 14, 1997
14204 4267 Abbott Bichromatic ABA 50 3703 Lactate Dehydrogenase Liver Fraction (LLDH) 2 HIGH July 26, 1993
14215 28183 Instrumentation Laboratory Multistat III 3703 Lactate Dehydrogenase Liver Fraction (LLDH) 2 HIGH July 26, 1993
14216 28184 Instrumentation Laboratory Multistat III Plus 3703 Lactate Dehydrogenase Liver Fraction (LLDH) 2 HIGH July 26, 1993
14234 7227 Behring Stat-Pack Lactate Test 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
14273 16010 Electronucleonics FLEXIGEM 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
14279 28183 Instrumentation Laboratory Multistat III 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
14280 28184 Instrumentation Laboratory Multistat III Plus 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
14366 7383 Beckman Auto ICS 3705 Lambda Light Chains 3 HIGH July 26, 1993
14371 25039 Helena Laboratories Titan IV Double Diffusion 3705 Lambda Light Chains 3 HIGH July 26, 1993
14374 25110 Helena Laboratories Fetal-Tek 200 Method L/S Ratio 3722 Lecithin/Sphingomyelin (L/S) Ratio 2 HIGH July 26, 1993
14375 25109 Helena Laboratories L/S Ratio 3722 Lecithin/Sphingomyelin (L/S) Ratio 2 HIGH July 26, 1993
14376 7125 Binax Equate Legionella Urinary Antigen RIA 3706 Legionella 8 HIGH July 26, 1993
14377 K934965 7527 Binax Legionella Urinary Antigen EIA 3706 Legionella 8 HIGH November 10, 1994
14378 22102 Gen-Probe Legionella Rapid Diagnostic System (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14379 22160 Gen-Probe Legionella Rapid Diagnostic System (including culture) 3706 Legionella 8 HIGH July 26, 1993
14380 22065 Genetic Systems Legionella IFA Test Kit (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14381 40098 MarDx Legionella DFA (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14382 40128 MarDx Legionella DFA (including culture) 3706 Legionella 8 HIGH July 26, 1993
14383 40035 Medical Diag. Technologies Legionella (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14384 40129 Medical Diag. Technologies Legionella (including culture) 3706 Legionella 8 HIGH July 26, 1993
14385 40096 Meridian Diagnostics MERIFLUOR Legionella (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14386 40127 Meridian Diagnostics MERIFLUOR Legionella (including culture) 3706 Legionella 8 HIGH July 26, 1993
14387 46099 Organon Teknika Legionella DFA Kit I (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14388 46124 Organon Teknika Legionella DFA Kit I (including culture) 3706 Legionella 8 HIGH July 26, 1993
14389 49031 Pro-Lab Legionella Latex Ag (including culture) 3706 Legionella 8 HIGH July 26, 1993
14390 55064 Remel Legionella Poly-ID Test Kit (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14391 55103 Remel Legionella Poly-ID Test Kit (including culture) 3706 Legionella 8 HIGH July 26, 1993
14392 58024 Scimedx Legionella Direct Fluorescent Test (direct antigen) 3706 Legionella 8 HIGH July 26, 1993
14393 79012 Zeus Scientific Legionella DFA (direct Ag) 3706 Legionella 8 HIGH July 26, 1993
14394 40010 MarDx Legionella IFA Test System 3707 Legionella Antibodies 3 HIGH July 26, 1993
14395 46033 Organon Teknika Legionella IFA Kit I 3707 Legionella Antibodies 3 HIGH July 26, 1993
14396 58455 Scimedx Legionella Indirect Ab Fluorescent Test System 3707 Legionella Antibodies 3 HIGH August 1, 1997
14398 K963318 70211 Wampole Legionella pneumophilia IgG/IgM ELISA 3707 Legionella Antibodies 3 HIGH January 23, 1998
14399 K970149 79055 Zeus Scientific Legionella (IgG/IgM/IgA) ELISA 3707 Legionella Antibodies 3 HIGH July 25, 1997
14400 79013 Zeus Scientific Legionella IFA Antibody 3707 Legionella Antibodies 3 HIGH July 26, 1993
14402 K991074 28575 INTRACEL Bartels Legionella Urinary Antigen ELISA (direct Ag/spectrophotometric) 3778 Legionella pneumophilia Serogroup 1 Antigen 3 HIGH January 27, 2000
14403 25047 Hillcrest Biologicals Leptospirosis IHA 3718 Leptospira Antibodies 3 HIGH July 26, 1993
14404 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 3749 Leucine 2 HIGH November 10, 1994
14405 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 3749 Leucine 2 HIGH May 26, 1995
14418 58051 Sigma Diagnostics Test Kit 3709 Leucine Aminopeptidase (LAP) 2 HIGH July 26, 1993
14419 7194 Bio/Data PAP-4 3716 Leukocyte Aggregation 4 HIGH July 26, 1993
14420 7193 Bio/Data PAP-4C 3716 Leukocyte Aggregation 4 HIGH July 26, 1993
14421 K970824 10404 ChromaVision MDx 2000 Digital Analyzer 3777 Leukocyte Alkaline Phosphatase (LAP) 4 HIGH September 19, 1997
14422 K936111 7538 BioTek Solutions TechMate {ChemMate Special Stain LCA-CD45} (tissue specimen) 3756 Leukocyte Common Antigen (LCA) 3 HIGH March 15, 1996
14459 28183 Instrumentation Laboratory Multistat III 3710 Lidocaine 7 HIGH July 26, 1993
14480 58082 Syva Emit Test Kit 3710 Lidocaine 7 HIGH July 26, 1993
14483 4035 Abbott Bichromatic ABA 100 3711 Lipase 2 HIGH July 26, 1993
14520 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 3711 Lipase 2 HIGH July 26, 1993
14530 16010 Electronucleonics FLEXIGEM 3711 Lipase 2 HIGH July 26, 1993
14541 28183 Instrumentation Laboratory Multistat III 3711 Lipase 2 HIGH July 26, 1993
14542 28184 Instrumentation Laboratory Multistat III Plus 3711 Lipase 2 HIGH July 26, 1993
14573 40126 Mallinckrodt Serometer 370 3711 Lipase 2 HIGH July 26, 1993
14574 K940457 40118 Meditech Diagnostic System Test Kit 3711 Lipase 2 HIGH October 14, 1994
14575 K923917 43090 NuClin Diagnostics ElIpAse 3711 Lipase 2 HIGH September 30, 1994
14594 49064 Pointe Scientific 180 Chemistry Analyzer 3711 Lipase 2 HIGH July 26, 1993
14613 K941085 58323 Sigma Diagnostics Lipase-PS (manual) 3711 Lipase 2 HIGH September 15, 1994
14614 58051 Sigma Diagnostics Test Kit 3711 Lipase 2 HIGH July 26, 1993
14615 58195 SmithKline ESKALAB-CCS 3711 Lipase 2 HIGH July 26, 1993
14616 58210 Stanbio Premiere 3711 Lipase 2 HIGH July 26, 1993
14617 58229 Sterling Diagnostics Analyzer 2000 3711 Lipase 2 HIGH July 26, 1993
14618 K915706 61416 TECO Diagnostics Lipase Reagent Set (manual) 3711 Lipase 2 HIGH March 26, 1999
14625 70102 Wako Autokit 3711 Lipase 2 HIGH July 26, 1993
14626 25098 Helena Laboratories Lipoprotein Electrophoresis Procedure 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14627 K962914 25273 Helena Laboratories REP 3 Auto-Flur Cholesterol-30 3720 Lipoprotein Fractions 2 HIGH June 13, 1997
14628 K935162 25179 Helena Laboratories REP Direct-Sep Cholesterol 3720 Lipoprotein Fractions 2 HIGH December 9, 1994
14629 25087 Helena Laboratories REP HDL Electrophoresis 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14630 K940679 25168 Helena Laboratories REP HDL/LDL-30 Electrophoresis System 3720 Lipoprotein Fractions 2 HIGH October 14, 1994
14631 25105 Helena Laboratories REP Lipo Electrophoresis Procedure 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14632 25104 Helena Laboratories REP Ultra HDL, VLDL/LDL Cholesterol System 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14633 K964471 25272 Helena Laboratories REP/REP 3 Flur Cholesterol-60 3720 Lipoprotein Fractions 2 HIGH June 13, 1997
14634 K980650 25307 Helena Laboratories REP/REP3 Cholesterol Profile Template-30 3720 Lipoprotein Fractions 2 HIGH December 10, 1999
14635 K980650 25306 Helena Laboratories REP/REP3 Vis Cholesterol 3720 Lipoprotein Fractions 2 HIGH December 10, 1999
14636 25096 Helena Laboratories Titan Gel HDL Electrophoresis System 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14637 25106 Helena Laboratories Titan Gel Lipoprotein Electrophoresis System 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14638 28178 Isolab LDL - Direct 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14639 28177 Isolab LDL - Direct Plus 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
14640 K974854 58603 Sebia HYDRASYS {Hydragel 7/15/30 LIPO} 3720 Lipoprotein Fractions 2 HIGH January 26, 2000
14641 K974854 58602 Sebia Hydragel -Mini LIPO/LIPO Kit (manual) 3720 Lipoprotein Fractions 2 HIGH January 26, 2000
14642 K960785 79049 Zaxis LFS Lipogel Assay Kit 3720 Lipoprotein Fractions 2 HIGH October 18, 1996
14649 K970302 49174 PerImmune Apo-Tek Lp(a) ELISA 3755 Lipoprotein(a) (Lp(a)) 2 HIGH November 14, 1997
14659 K971157 58515 Strategic Diagnostics MACRA Lp(a) ELISA 3755 Lipoprotein(a) (Lp(a)) 2 HIGH June 5, 1998
14662 22040 Gen-Probe AccuProbe (including culture) 3719 Listeria monocytogenes 8 HIGH July 26, 1993
14682 28062 Instrumentation Laboratory AA Spectro 3712 Lithium 7 HIGH July 26, 1993
14684 28081 Instrumentation Laboratory IL Flame Photometer/Elect 3712 Lithium 7 HIGH July 26, 1993
14739 55007 Radiometer Flame Photometer 3712 Lithium 7 HIGH July 26, 1993
14743 4543 American Diagnostica DVVtest/DVVconfirm (manual) 3728 Lupus Anticoagulants 4 HIGH October 28, 1994
14744 K940490 7691 Becton Dickinson BBL Fibrometer {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14745 K940490 7692 Bio/Data MCA 210 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14747 K940490 7693 Bio/Data MCA 310 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14748 K970431 13608 Dade Behring Coagulation System (BCS) 3728 Lupus Anticoagulants 4 HIGH January 26, 2000
14749 K940490 13405 Diagnostica Stago ST4 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14750 K923731 13285 Diagnostica Stago STACLOT LA 3728 Lupus Anticoagulants 4 HIGH November 22, 1993
14751 K924370 13273 Diagnostica Stago STACLOT PNP 3728 Lupus Anticoagulants 4 HIGH November 22, 1993
14752 K940490 22179 General Diagnostics Coag-A-Mate X2 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14753 K922156 22163 Gradipore Lupo-Test II & Lucor 3728 Lupus Anticoagulants 4 HIGH November 22, 1993
14754 K940490 28412 Instrumentation Laboratory IL ACL 300 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14755 K940490 28413 Instrumentation Laboratory IL ACL 300 Plus {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14756 K990302 28601 Instrumentation Laboratory IL ACL Futura System {LAC Screen/Confirm} 3728 Lupus Anticoagulants 4 HIGH January 26, 2000
14757 K940490 40228 Medical Laboratory MLA Electra 700 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14758 K940490 40229 Medical Laboratory MLA Electra 800 {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14759 K940490 40230 Medical Laboratory MLA Electra 900C {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14760 K940490 40231 Medical Laboratory MLA Electra1000C {American Diagnostica DVVtest/DVVconfirm} 3728 Lupus Anticoagulants 4 HIGH September 29, 1995
14765 E990033 4861 Alfa Scientific Designs Luteinizing Hormone (LH) EIA 3713 Luteinizing Hormone (LH) 6 HIGH July 23, 1999
14767 4148 Amersham Amerlite 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14774 7106 Becton Dickinson SimulTRAC 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14786 10055 Ciba Corning Magic Lite 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14789 10061 Clinical Assays GammaDab 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14795 13109 Diagnostic Products Corp. Coat-A-Count IRMA 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14796 13031 Diagnostic Products Corp. Double Antibody 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14797 13111 Diagnostic Products Corp. Milenia 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14798 K961109 13417 Diagnostic Systems DSL 4600 ACTIVE LH Coated-Tube IRMA 3713 Luteinizing Hormone (LH) 6 HIGH May 10, 1996
14803 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14804 25053 Hybritech Photon Immunoassay Analyzer 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14805 25022 Hybritech Tandem-E 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14806 K922944 28269 ICN ImmuChem LH-MW ELISA Kit 3713 Luteinizing Hormone (LH) 6 HIGH November 22, 1993
14807 28174 Immunotech EZ-TUBE EIA Kit 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14809 E990028 34096 KMI Diagnostics LH ELISA 3713 Luteinizing Hormone (LH) 6 HIGH March 26, 1999
14810 37029 Leeco Diagnostics RIA Test Kit 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14811 40117 Medix Biotech EIA Test Kit 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14812 43008 Nichols Institute Allegro RIA 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14813 K935319 43107 Nichols Institute Chemiluminescence LH Assay 3713 Luteinizing Hormone (LH) 6 HIGH September 15, 1995
14814 46007 Organon NML IRMA Test Kit 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14825 K964925 58439 SeaLite Sciences AquaLite LH (computer calculations) 3713 Luteinizing Hormone (LH) 6 HIGH March 7, 1997
14826 K943188 58339 SeaLite Sciences AquaLite LH (manual curve) 3713 Luteinizing Hormone (LH) 6 HIGH February 17, 1995
14828 58091 Serono Baker Serozyme 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14830 58251 Serono Diagnostics Serozyme 3713 Luteinizing Hormone (LH) 6 HIGH July 26, 1993
14839 70150 Wallac Oy DELFIA hLH Kit 3713 Luteinizing Hormone (LH) 6 HIGH September 1, 1994
14840 70151 Wallac Oy DELFIA hLH Spec Kit 3713 Luteinizing Hormone (LH) 6 HIGH September 1, 1994
14842 4328 Analytab API Lyme ELISA Test Kit 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14843 K922578 7509 Baxter Bartels B. burgdorferi (Lyme) IgM PRIMA System EIA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH November 22, 1993
14844 7298 Baxter Bartels PRIMA Lyme Disease EIA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14845 7317 BioWhittaker 3M IgG/IgM FASTLYME Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14846 7328 BioWhittaker FIAX System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14847 7332 BioWhittaker LYME STAT 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14848 7333 BioWhittaker LYME STAT M 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14849 K980351 8193 Boston Biomedica BBI-Biotech B. burgdorferi IgM Western Blot 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH May 24, 1999
14850 K971169 10443 Cambridge Biotech Human Lyme B. burgdorferi IgG Western Blot 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 12, 1998
14851 K971170 10444 Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 12, 1998
14852 10009 Cambridge Biotech Human Lyme EIA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14853 K970761 10446 Cambridge Diagnostics Ireland Human Lyme B. burgdorferi IgG Western Blot 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 19, 1998
14854 K970768 10447 Cambridge Diagnostics Ireland Human Lyme B. burgdorferi IgM Western Blot 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 19, 1998
14855 K983605 13572 Diamedix Immunosimplicity (Is)-anti-Borrelia burgdorferi IgG/IgM (manual) 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH November 19, 1999
14856 K983606 13570 Diamedix Immunosimplicity (Is)-anti-Borrelia burgdorferi IgM (manual) 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH November 19, 1999
14857 13244 Diamedix Lyme Disease Microassay 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14858 13170 Diamedix Lyme IgM Microassay 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14864 22197 GenBio ImmunoWELL Borrelia (Lyme) Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH August 1, 1997
14865 22203 GenBio ImmunoWELL Recombinant P39 (Lyme) Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH August 1, 1997
14870 22048 General Biometrics ImmunoWELL Borrelia (Lyme) Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14871 22054 General Biometrics ImmunoWELL Recombinant P39 (Lyme) Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14872 K903013 22089 Gull Laboratories Lyme IgM ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14873 25050 Hillcrest Biologicals Lyme Disease ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14874 25044 Hillcrest Biologicals Lyme Disease IFA (IgG) Test 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14875 K984222 28559 INOVA Diagnostics QUANTA Lite Lyme B. burgdorferi IgG ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH May 7, 1999
14877 K984234 28558 INOVA Diagnostics QUANTA Lite Lyme B. burgdorferi IgM ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH May 7, 1999
14878 K950829 40206 MarDx Lyme Disease (IgG) Marblot Strip Test System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 14, 1996
14879 K951709 40210 MarDx Lyme Disease (IgM) Marblot Strip Test System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH June 14, 1996
14880 40011 MarDx Lyme Disease EIA (IgM & IgG) 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14881 40012 MarDx Lyme Disease EIA IgG 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14882 40013 MarDx Lyme Disease EIA IgM 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14883 40014 MarDx Lyme Disease IgG IFA Test System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14884 40015 MarDx Lyme Disease IgM IFA Test System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14887 58137 Sanofi Pasteur Platelia Lyme 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14888 58025 Scimedx Lyme Detect Test System 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14890 58100 Sigma Diagnostics SIA Lyme Disease 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14893 K965131 70218 Wampole Borrelia burgdorferi IgG/IgM ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH April 10, 1998
14894 K965129 70217 Wampole Borrelia burgdorferi IgM ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH April 10, 1998
14896 79014 Zeus Scientific Lyme Disease IFA Antibody 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14897 79015 Zeus Scientific Lyme ELISA Combo 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14898 79016 Zeus Scientific Lyme IgG ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
14900 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3759 Lymphocytes, CD19 3 HIGH September 1, 1994
14901 K884020 10329 Coulter EPICS Profile 3759 Lymphocytes, CD19 3 HIGH May 10, 1996
14902 K884020 10219 Coulter EPICS Profile II 3759 Lymphocytes, CD19 3 HIGH May 10, 1996
14903 K884020 10331 Coulter EPICS XL-MCL 3759 Lymphocytes, CD19 3 HIGH May 10, 1996
14904 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3759 Lymphocytes, CD19 3 HIGH January 7, 2000
14905 10246 Coulter Epics Flow Cytometer 3759 Lymphocytes, CD19 3 HIGH September 1, 1994
14906 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3763 Lymphocytes, CD2 3 HIGH September 1, 1994
14907 K875047 10329 Coulter EPICS Profile 3763 Lymphocytes, CD2 3 HIGH May 10, 1996
14908 K875047 10219 Coulter EPICS Profile II 3763 Lymphocytes, CD2 3 HIGH May 10, 1996
14909 K875047 10331 Coulter EPICS XL-MCL 3763 Lymphocytes, CD2 3 HIGH May 10, 1996
14910 10246 Coulter Epics Flow Cytometer 3763 Lymphocytes, CD2 3 HIGH September 1, 1994
14911 K910473 10329 Coulter EPICS Profile 3773 Lymphocytes, CD2/CD19 3 HIGH May 10, 1996
14912 K910473 10219 Coulter EPICS Profile II 3773 Lymphocytes, CD2/CD19 3 HIGH May 10, 1996
14913 K910473 10330 Coulter EPICS XL 3773 Lymphocytes, CD2/CD19 3 HIGH May 10, 1996
14914 K910473 10331 Coulter EPICS XL-MCL 3773 Lymphocytes, CD2/CD19 3 HIGH May 10, 1996
14915 10246 Coulter Epics Flow Cytometer 3773 Lymphocytes, CD2/CD19 3 HIGH September 1, 1994
14916 K884346 10329 Coulter EPICS Profile 3772 Lymphocytes, CD2/CD20 3 HIGH May 10, 1996
14917 K884346 10219 Coulter EPICS Profile II 3772 Lymphocytes, CD2/CD20 3 HIGH May 10, 1996
14918 K884346 10330 Coulter EPICS XL 3772 Lymphocytes, CD2/CD20 3 HIGH May 10, 1996
14919 K884346 10331 Coulter EPICS XL-MCL 3772 Lymphocytes, CD2/CD20 3 HIGH May 10, 1996
14920 10246 Coulter Epics Flow Cytometer 3772 Lymphocytes, CD2/CD20 3 HIGH September 1, 1994
14921 K882557 10329 Coulter EPICS Profile 3758 Lymphocytes, CD20 3 HIGH May 10, 1996
14922 K882557 10219 Coulter EPICS Profile II 3758 Lymphocytes, CD20 3 HIGH May 10, 1996
14923 K882557 10330 Coulter EPICS XL 3758 Lymphocytes, CD20 3 HIGH May 10, 1996
14924 K882557 10331 Coulter EPICS XL-MCL 3758 Lymphocytes, CD20 3 HIGH May 10, 1996
14925 10246 Coulter Epics Flow Cytometer 3758 Lymphocytes, CD20 3 HIGH September 1, 1994
14926 K933486 7601 Becton Dickinson FACSCount 3760 Lymphocytes, CD3 3 HIGH December 23, 1994
14927 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3760 Lymphocytes, CD3 3 HIGH September 1, 1994
14928 K911793 10329 Coulter EPICS Profile 3760 Lymphocytes, CD3 3 HIGH May 10, 1996
14929 K911793 10219 Coulter EPICS Profile II 3760 Lymphocytes, CD3 3 HIGH May 10, 1996
14930 K911793 10330 Coulter EPICS XL 3760 Lymphocytes, CD3 3 HIGH May 10, 1996
14931 K982172 10466 Coulter EPICS XL System {CYTO-STAT CD3-FITC/CD56-RD1} 3760 Lymphocytes, CD3 3 HIGH May 7, 1999
14932 K911793 10331 Coulter EPICS XL-MCL 3760 Lymphocytes, CD3 3 HIGH May 10, 1996
14933 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3760 Lymphocytes, CD3 3 HIGH January 7, 2000
14934 K911793 10246 Coulter Epics Flow Cytometer 3760 Lymphocytes, CD3 3 HIGH September 1, 1994
14935 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3783 Lymphocytes, CD3-/CD56+ 3 HIGH January 7, 2000
14936 K926124 10329 Coulter EPICS Profile 3765 Lymphocytes, CD3/CD19 3 HIGH May 10, 1996
14937 K926124 10219 Coulter EPICS Profile II 3765 Lymphocytes, CD3/CD19 3 HIGH May 10, 1996
14938 K926124 10330 Coulter EPICS XL 3765 Lymphocytes, CD3/CD19 3 HIGH May 10, 1996
14939 K926124 10331 Coulter EPICS XL-MCL 3765 Lymphocytes, CD3/CD19 3 HIGH May 10, 1996
14940 K950342 7497 Becton Dickinson FACScan 3768 Lymphocytes, CD3/CD19/CD45 3 HIGH February 23, 1996
14941 K950342 7637 Becton Dickinson FACSort 3768 Lymphocytes, CD3/CD19/CD45 3 HIGH February 23, 1996
14942 K933486 7601 Becton Dickinson FACSCount 3766 Lymphocytes, CD3/CD4 3 HIGH December 23, 1994
14943 K922745 10329 Coulter EPICS Profile 3766 Lymphocytes, CD3/CD4 3 HIGH May 10, 1996
14944 K922745 10219 Coulter EPICS Profile II 3766 Lymphocytes, CD3/CD4 3 HIGH May 10, 1996
14945 K922745 10330 Coulter EPICS XL 3766 Lymphocytes, CD3/CD4 3 HIGH May 10, 1996
14946 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3766 Lymphocytes, CD3/CD4 3 HIGH January 7, 2000
14947 K922745 10246 Coulter Epics Flow Cytometer 3766 Lymphocytes, CD3/CD4 3 HIGH November 22, 1993
14948 K946055 7497 Becton Dickinson FACScan 3769 Lymphocytes, CD3/CD4/CD45 3 HIGH February 23, 1996
14949 K962768 10396 Coulter EPICS XL System {CYTO-COMP/ImmunoPrep} 3769 Lymphocytes, CD3/CD4/CD45 3 HIGH April 11, 1997
14950 K962768 10397 Coulter Profile System {CYTO-COMP/ImmunoPrep} 3769 Lymphocytes, CD3/CD4/CD45 3 HIGH April 11, 1997
14951 K950742 10329 Coulter EPICS Profile 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH May 10, 1996
14952 K950742 10219 Coulter EPICS Profile II 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH May 10, 1996
14953 K950742 10330 Coulter EPICS XL 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH May 10, 1996
14954 K964618 10396 Coulter EPICS XL System {CYTO-COMP/ImmunoPrep} 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH April 11, 1997
14955 K950742 10331 Coulter EPICS XL-MCL 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH May 10, 1996
14956 K950742 10246 Coulter Epics Flow Cytometer 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH September 1, 1995
14957 K964618 10397 Coulter Profile System {CYTO-COMP/ImmunoPrep} 3771 Lymphocytes, CD3/CD4/CD8 3 HIGH April 11, 1997
14958 K963263 10395 Coulter EPICS XL/tetraONE System {CYTO-COMP/ImmunoPrep} 3775 Lymphocytes, CD3/CD4/CD8/CD45 3 HIGH April 11, 1997
14959 K922744 10329 Coulter EPICS Profile 3767 Lymphocytes, CD3/CD8 3 HIGH May 10, 1996
14960 K922744 10219 Coulter EPICS Profile II 3767 Lymphocytes, CD3/CD8 3 HIGH May 10, 1996
14961 K922744 10330 Coulter EPICS XL 3767 Lymphocytes, CD3/CD8 3 HIGH May 10, 1996
14962 K922744 10331 Coulter EPICS XL-MCL 3767 Lymphocytes, CD3/CD8 3 HIGH May 10, 1996
14963 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3767 Lymphocytes, CD3/CD8 3 HIGH January 7, 2000
14964 K922744 10246 Coulter Epics Flow Cytometer 3767 Lymphocytes, CD3/CD8 3 HIGH November 22, 1993
14965 K962305 10396 Coulter EPICS XL System {CYTO-COMP/ImmunoPrep} 3776 Lymphocytes, CD3/CD8/CD45 3 HIGH April 11, 1997
14966 K962305 10397 Coulter Profile System {CYTO-COMP/ImmunoPrep} 3776 Lymphocytes, CD3/CD8/CD45 3 HIGH April 11, 1997
14967 K924587 7497 Becton Dickinson FACScan 3770 Lymphocytes, CD3/HLA-DR 3 HIGH November 22, 1993
14970 K921279 10248 Coulter CD4 Cyto-Spheres Kit 3761 Lymphocytes, CD4 3 HIGH November 22, 1993
14971 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3761 Lymphocytes, CD4 3 HIGH September 1, 1994
14972 K893852 10329 Coulter EPICS Profile 3761 Lymphocytes, CD4 3 HIGH May 10, 1996
14973 K893852 10219 Coulter EPICS Profile II 3761 Lymphocytes, CD4 3 HIGH May 10, 1996
14974 K893852 10330 Coulter EPICS XL 3761 Lymphocytes, CD4 3 HIGH May 10, 1996
14975 K893852 10331 Coulter EPICS XL-MCL 3761 Lymphocytes, CD4 3 HIGH May 10, 1996
14976 K893852 10246 Coulter Epics Flow Cytometer 3761 Lymphocytes, CD4 3 HIGH September 1, 1994
14978 K895917 10329 Coulter EPICS Profile 3774 Lymphocytes, CD4/CD8 3 HIGH May 10, 1996
14979 K895917 10219 Coulter EPICS Profile II 3774 Lymphocytes, CD4/CD8 3 HIGH May 10, 1996
14980 K895917 10330 Coulter EPICS XL 3774 Lymphocytes, CD4/CD8 3 HIGH May 10, 1996
14981 K895917 10331 Coulter EPICS XL-MCL 3774 Lymphocytes, CD4/CD8 3 HIGH May 10, 1996
14982 K982167 10465 Coulter EPICS XL System {CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5} 3782 Lymphocytes, CD45/CD19 3 HIGH April 23, 1999
14983 K982167 10465 Coulter EPICS XL System {CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5} 3780 Lymphocytes, CD45/CD3 3 HIGH April 23, 1999
14984 K982166 10464 Coulter EPICS XL System {CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5} 3780 Lymphocytes, CD45/CD3 3 HIGH April 23, 1999
14985 K982166 10464 Coulter EPICS XL System {CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5} 3781 Lymphocytes, CD45/CD56 3 HIGH April 23, 1999
14986 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3762 Lymphocytes, CD5 3 HIGH September 1, 1994
14987 K883753 10329 Coulter EPICS Profile 3762 Lymphocytes, CD5 3 HIGH May 10, 1996
14988 K883753 10219 Coulter EPICS Profile II 3762 Lymphocytes, CD5 3 HIGH May 10, 1996
14989 K883753 10330 Coulter EPICS XL 3762 Lymphocytes, CD5 3 HIGH May 10, 1996
14990 K883753 10331 Coulter EPICS XL-MCL 3762 Lymphocytes, CD5 3 HIGH May 10, 1996
14991 K982172 10466 Coulter EPICS XL System {CYTO-STAT CD3-FITC/CD56-RD1} 3779 Lymphocytes, CD56 3 HIGH May 7, 1999
14994 K923951 10270 Coulter CD8 Cyto-Spheres Kit 3764 Lymphocytes, CD8 3 HIGH November 10, 1994
14995 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3764 Lymphocytes, CD8 3 HIGH September 1, 1994
14996 K893853 10329 Coulter EPICS Profile 3764 Lymphocytes, CD8 3 HIGH May 10, 1996
14997 K893853 10219 Coulter EPICS Profile II 3764 Lymphocytes, CD8 3 HIGH May 10, 1996
14998 K893853 10330 Coulter EPICS XL 3764 Lymphocytes, CD8 3 HIGH May 10, 1996
14999 K893853 10331 Coulter EPICS XL-MCL 3764 Lymphocytes, CD8 3 HIGH May 10, 1996
15000 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3764 Lymphocytes, CD8 3 HIGH January 7, 2000
15004 K955814 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 3715 Lysergic Acid Diethylamide (LSD) 7 HIGH March 15, 1996
15005 13030 Diagnostic Products Corp. Coat-A-Count 3715 Lysergic Acid Diethylamide (LSD) 7 HIGH July 26, 1993
15006 55098 Roche Diagnostics Abuscreen RIA 3715 Lysergic Acid Diethylamide (LSD) 7 HIGH July 26, 1993
15010 K955814 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 3715 Lysergic Acid Diethylamide (LSD) 7 HIGH May 7, 1999
15011 K954073 58395 STC Technologies LSD Micro-Plate EIA 3715 Lysergic Acid Diethylamide (LSD) 7 HIGH March 1, 1996
15012 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 3750 Lysine 2 HIGH November 10, 1994
15013 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 3750 Lysine 2 HIGH May 26, 1995
15014 34003 Kallestad Quantiplate RID 3717 Lysozyme 2 HIGH July 26, 1993
15017 4036 Abbott Bichromatic ABA 200 4002 Magnesium 2 HIGH July 26, 1993
15018 4267 Abbott Bichromatic ABA 50 4002 Magnesium 2 HIGH July 26, 1993
15029 4143 American Monitor KDA 4002 Magnesium 2 HIGH July 26, 1993
15066 13216 DMA Test Kit 4002 Magnesium 2 HIGH July 26, 1993
15074 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 4002 Magnesium 2 HIGH July 26, 1993
15086 16010 Electronucleonics FLEXIGEM 4002 Magnesium 2 HIGH July 26, 1993
15090 K930074 25178 Horizon Diagnostics Magnesium (manual) 4002 Magnesium 2 HIGH December 9, 1994
15098 28183 Instrumentation Laboratory Multistat III 4002 Magnesium 2 HIGH July 26, 1993
15099 28184 Instrumentation Laboratory Multistat III Plus 4002 Magnesium 2 HIGH July 26, 1993
15118 K923927 34051 King Diagnostics Test Kit 4002 Magnesium 2 HIGH November 22, 1993
15131 40126 Mallinckrodt Serometer 370 4002 Magnesium 2 HIGH July 26, 1993
15132 40124 Medical Analysis Systems RefLab Test Kit 4002 Magnesium 2 HIGH July 26, 1993
15160 49064 Pointe Scientific 180 Chemistry Analyzer 4002 Magnesium 2 HIGH July 26, 1993
15162 55075 Reagents Applications RAICHEM Test Kit (manual) 4002 Magnesium 2 HIGH July 26, 1993
15182 58165 Sherwood Medical Rapid Stat Diagnostic Kit 4002 Magnesium 2 HIGH July 26, 1993
15183 58051 Sigma Diagnostics Test Kit 4002 Magnesium 2 HIGH July 26, 1993
15184 58195 SmithKline ESKALAB-CCS 4002 Magnesium 2 HIGH July 26, 1993
15185 58210 Stanbio Premiere 4002 Magnesium 2 HIGH July 26, 1993
15186 58229 Sterling Diagnostics Analyzer 2000 4002 Magnesium 2 HIGH July 26, 1993
15188 K874847 61417 TECO Diagnostics Magnesium Reagent Set (manual) 4002 Magnesium 2 HIGH March 26, 1999
15189 K882938 61377 TECO Diagnostics TC 84 4002 Magnesium 2 HIGH November 19, 1998
15190 61044 TRACE Scientific Test Kit 4002 Magnesium 2 HIGH July 26, 1993
15204 70107 Wako Magnesium B Test Kit 4002 Magnesium 2 HIGH July 26, 1993
15209 4264 All Permanent Stain Preparations 4021 Malarial Parasite 11 HIGH July 26, 1993
15210 7214 Becton Dickinson QBC Blood Parasite Detection Method 4021 Malarial Parasite 11 HIGH July 26, 1993
15211 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 4025 Metanephrines 6 HIGH August 23, 1996
15212 7279 Bio-Rad HPLC 4025 Metanephrines 6 HIGH July 26, 1993
15213 K952919 7686 Bioanalytical Systems Urinary Metanephrine Kit 4025 Metanephrines 6 HIGH September 8, 1995
15214 E990013 34111 KMI Diagnostics 125 I-METCOMBI RIA 4025 Metanephrines 6 HIGH April 2, 1999
15215 K931148 16043 esa Coulochem Electrode Array System (CEAS) 4025 Metanephrines 6 HIGH November 22, 1993
15220 4275 Ames OPTIMATE 4003 Methadone 7 HIGH July 26, 1993
15234 K954227 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH March 29, 1996
15239 K954227 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH March 29, 1996
15244 K954227 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH March 29, 1996
15247 K954227 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH March 29, 1996
15251 K954227 7768 Boehringer Mannheim Hitachi 917 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH March 29, 1996
15279 28183 Instrumentation Laboratory Multistat III 4003 Methadone 7 HIGH July 26, 1993
15280 28184 Instrumentation Laboratory Multistat III Plus 4003 Methadone 7 HIGH July 26, 1993
15314 K954227 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH May 7, 1999
15318 K954227 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH May 7, 1999
15324 K954227 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH May 7, 1999
15327 K954227 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH May 7, 1999
15337 58188 Syva Emit st Drug Detection System 4003 Methadone 7 HIGH July 26, 1993
15338 58190 Syva Qstat/Qst System 4003 Methadone 7 HIGH July 26, 1993
15376 13030 Diagnostic Products Corp. Coat-A-Count 4004 Methamphetamines 7 HIGH July 26, 1993
15377 13111 Diagnostic Products Corp. Milenia 4004 Methamphetamines 7 HIGH July 26, 1993
15380 19013 Finnigan MAT Witness System 4004 Methamphetamines 7 HIGH July 26, 1993
15406 55098 Roche Diagnostics Abuscreen RIA 4004 Methamphetamines 7 HIGH July 26, 1993
15415 K935573 58381 STC Technologies Methamphetamine M-Plate EIA {Sudormed Patch} 4004 Methamphetamines 7 HIGH September 8, 1995
15416 58103 Sigma Diagnostics SIA Methamphetamine/Amphetamine 4004 Methamphetamines 7 HIGH July 26, 1993
15430 4275 Ames OPTIMATE 4005 Methaqualone 7 HIGH July 26, 1993
15461 55098 Roche Diagnostics Abuscreen RIA 4005 Methaqualone 7 HIGH July 26, 1993
15478 58188 Syva Emit st Drug Detection System 4005 Methaqualone 7 HIGH July 26, 1993
15502 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4031 Methionine 2 HIGH November 10, 1994
15503 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 4031 Methionine 2 HIGH May 26, 1995
15513 28183 Instrumentation Laboratory Multistat III 4006 Methotrexate 7 HIGH July 26, 1993
15514 28184 Instrumentation Laboratory Multistat III Plus 4006 Methotrexate 7 HIGH July 26, 1993
15519 58082 Syva Emit Test Kit 4006 Methotrexate 7 HIGH July 26, 1993
15520 K970932 4731 ALPCO ORGenTec Micro-Albumin EIA 4019 Microalbumin 2 HIGH July 25, 1997
15521 K960274 4663 ALPCO ORGenTec Micro-Albumin Pin Immuno Assay 4019 Microalbumin 2 HIGH May 3, 1996
15542 13031 Diagnostic Products Corp. Double Antibody 4019 Microalbumin 2 HIGH July 26, 1993
15546 28183 Instrumentation Laboratory Multistat III 4019 Microalbumin 2 HIGH July 26, 1993
15547 28184 Instrumentation Laboratory Multistat III Plus 4019 Microalbumin 2 HIGH July 26, 1993
15561 K935662 58322 Synermed IR 500 4019 Microalbumin 2 HIGH September 15, 1994
15563 K944664 70173 Wako Micro-Albumin B (manual) 4019 Microalbumin 2 HIGH August 18, 1995
15564 70105 Wako Micro-Albumin Turbidimetric Test Kit (urine) 4019 Microalbumin 2 HIGH July 26, 1993
15565 4036 Abbott Bichromatic ABA 200 4026 Microprotein, CSF 2 HIGH July 26, 1993
15585 13216 DMA Test Kit 4026 Microprotein, CSF 2 HIGH September 1, 1994
15594 34050 Kenlor Industries Test Kit 4026 Microprotein, CSF 2 HIGH July 26, 1993
15616 58051 Sigma Diagnostics Test Kit 4026 Microprotein, CSF 2 HIGH July 26, 1993
15617 58229 Sterling Diagnostics Analyzer 2000 4026 Microprotein, CSF 2 HIGH July 26, 1993
15624 4036 Abbott Bichromatic ABA 200 4027 Microprotein, Urine 2 HIGH July 26, 1993
15654 34050 Kenlor Industries Test Kit 4027 Microprotein, Urine 2 HIGH July 26, 1993
15675 58229 Sterling Diagnostics Analyzer 2000 4027 Microprotein, Urine 2 HIGH July 26, 1993
15676 K961864 61280 TECO Diagnostics CSF/Urine Total Protein (manual) 4027 Microprotein, Urine 2 HIGH April 4, 1997
15677 K925794 61044 TRACE Scientific Test Kit 4027 Microprotein, Urine 2 HIGH February 17, 1995
15684 K960090 55206 Remel Calcofluor White Stain Kit 4039 Microsporidia 11 HIGH May 17, 1996
15685 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 4040 Monocytes, CD14 (MY4) 3 HIGH September 1, 1994
15686 K894179 10329 Coulter EPICS Profile 4040 Monocytes, CD14 (MY4) 3 HIGH May 10, 1996
15687 K894179 10219 Coulter EPICS Profile II 4040 Monocytes, CD14 (MY4) 3 HIGH May 10, 1996
15688 K894179 10331 Coulter EPICS XL-MCL 4040 Monocytes, CD14 (MY4) 3 HIGH May 10, 1996
15689 10246 Coulter Epics Flow Cytometer 4040 Monocytes, CD14 (MY4) 3 HIGH September 1, 1994
15690 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 4041 Monocytes, CD14 (Mo2) 3 HIGH September 1, 1994
15691 K884605 10329 Coulter EPICS Profile 4041 Monocytes, CD14 (Mo2) 3 HIGH May 10, 1996
15692 K884605 10219 Coulter EPICS Profile II 4041 Monocytes, CD14 (Mo2) 3 HIGH May 10, 1996
15693 K884605 10330 Coulter EPICS XL 4041 Monocytes, CD14 (Mo2) 3 HIGH May 10, 1996
15694 10246 Coulter Epics Flow Cytometer 4041 Monocytes, CD14 (Mo2) 3 HIGH September 1, 1994
15695 K954783 13408 Difco DrySlide CATARRALIS (including culture) 4037 Moraxella catarrhalis 8 HIGH February 9, 1996
15700 13030 Diagnostic Products Corp. Coat-A-Count 4020 Morphine 7 HIGH July 26, 1993
15711 K933572 28342 Immunalysis Urine Morphine Direct RIA Kit 4020 Morphine 7 HIGH September 30, 1994
15713 55098 Roche Diagnostics Abuscreen RIA 4020 Morphine 7 HIGH July 26, 1993
15728 K945519 22181 Glyco FACE Qualitative Urinary Carbohydrate Analysis Kit 4038 Mucopolysaccharides, Urinary 2 HIGH March 15, 1996
15729 7328 BioWhittaker FIAX System 4007 Mumps Antibodies 3 HIGH July 26, 1993
15730 7337 BioWhittaker MUMPSTAT 4007 Mumps Antibodies 3 HIGH July 26, 1993
15732 K926066 7480 Bion Mumps-G Antibody Test System 4007 Mumps Antibodies 3 HIGH November 22, 1993
15733 K991274 13580 Diamedix Immunosimplicity (Is)-Mumps IgG (manual) 4007 Mumps Antibodies 3 HIGH November 19, 1999
15736 K971857 22232 Gull Laboratories Mumps IgG ELISA (manual/qualitative) 4007 Mumps Antibodies 3 HIGH February 27, 1998
15737 K971857 22231 Gull Laboratories Mumps IgG ELISA (manual/semi-quantitative) 4007 Mumps Antibodies 3 HIGH February 27, 1998
15738 49020 Pharmacia Mumps IgG ELISA 4007 Mumps Antibodies 3 HIGH July 26, 1993
15739 K980059 52097 Quest International SeraQuest Mumps IgG (manual/qualitative) 4007 Mumps Antibodies 3 HIGH July 17, 1998
15740 K980059 52098 Quest International SeraQuest Mumps IgG (manual/semi-quantitative) 4007 Mumps Antibodies 3 HIGH July 17, 1998
15742 K980059 52100 Quest International SeraQuest Mumps IgG {Hyperion HyPrep Plus} (manual calculations) 4007 Mumps Antibodies 3 HIGH July 17, 1998
15744 67025 Virgo Mumps Antibody IFA Test 4007 Mumps Antibodies 3 HIGH July 26, 1993
15746 K961204 79051 Zeus Scientific Mumps IgG ELISA 4007 Mumps Antibodies 3 HIGH November 8, 1996
15748 4101 All Acid-Fast Concentrated Smear Test Systems & Procedures 4024 Mycobacteria 9 HIGH July 26, 1993
15750 4103 All Manual Antimycobacterial Susceptibility Procedures 4024 Mycobacteria 9 HIGH July 26, 1993
15751 4371 All Organism Identification from Culture 4024 Mycobacteria 9 HIGH July 26, 1993
15752 K946268 7746 Becton Dickinson BACTEC 9000MB 4024 Mycobacteria 9 HIGH May 24, 1996
15753 K974883 8189 Becton Dickinson BACTEC MGIT 960 System 4024 Mycobacteria 9 HIGH April 23, 1999
15754 K954932 7808 Becton Dickinson BBL MGIT/Mycobacteria Growth Indicator 4024 Mycobacteria 9 HIGH October 25, 1996
15755 K953129 13399 Difco ESP Culture System II 4024 Mycobacteria 9 HIGH January 27, 2000
15756 K981736 46292 Organon Teknika BacT/ALERT 3D 4024 Mycobacteria 9 HIGH October 16, 1998
15757 K954468 46215 Organon Teknika MB {BacT Microbial Detection System} 4024 Mycobacteria 9 HIGH July 26, 1996
15758 22129 Gen-Probe AccuProbe - M. avium specific (including culture) 4008 Mycobacterium avium 9 HIGH September 22, 1995
15759 K943049 13383 DynaGen MycoAKT Kit for M. avium Complex (including culture) 4009 Mycobacterium avium complex 9 HIGH September 22, 1995
15760 22128 Gen-Probe AccuProbe - M. avium complex (including culture) 4009 Mycobacterium avium complex 9 HIGH September 22, 1995
15761 K943049 55217 Remel MycoAKT Culture ID M. avium complex (including culture) 4009 Mycobacterium avium complex 9 HIGH December 6, 1996
15762 58069 Syngene Snap Culture ID Diagnostic Kit - M. avium complex 4009 Mycobacterium avium complex 9 HIGH September 22, 1995
15763 22131 Gen-Probe AccuProbe - M. intracellulare specific (including culture) 4012 Mycobacterium intracellulare 9 HIGH September 22, 1995
15764 K943050 13384 DynaGen MycoAKT Kit for M. kansasii (including culture) 4014 Mycobacterium kansasii 9 HIGH September 22, 1995
15765 22127 Gen-Probe AccuProbe - M. kansasii (including culture) 4014 Mycobacterium kansasii 9 HIGH September 22, 1995
15766 K943050 55218 Remel MycoAKT Culture ID M. kansasii (including culture) 4014 Mycobacterium kansasii 9 HIGH December 6, 1996
15767 7084 Becton Dickinson BACTEC TB System (NAP differentiation test) 4015 Mycobacterium tuberculosis complex 9 HIGH September 22, 1995
15768 7222 Becton Dickinson BACTEC TB System (susceptibility test) 4015 Mycobacterium tuberculosis complex 9 HIGH September 22, 1995
15769 K943051 13385 DynaGen MycoAKT Kit for M. tuberculosis Complex (including culture) 4015 Mycobacterium tuberculosis complex 9 HIGH September 22, 1995
15770 P940034 22276 Gen-Probe AMPLIFIED Mycobacterium Tuberculosis Direct (MTD) Test 4015 Mycobacterium tuberculosis complex 9 HIGH January 27, 2000
15771 22132 Gen-Probe AccuProbe - M. tuberculosis complex (including culture) 4015 Mycobacterium tuberculosis complex 9 HIGH September 22, 1995
15772 K943051 55216 Remel MycoAKT Culture ID M. tuberculosis cplx (including culture) 4015 Mycobacterium tuberculosis complex 9 HIGH December 6, 1996
15773 58152 Syngene Snap Culture ID Diagnostic Kit - M. tuberculosis cplx 4015 Mycobacterium tuberculosis complex 9 HIGH September 22, 1995
15774 22103 Gen-Probe M. pneumoniae Rapid Diagnostic System (direct Ag) 4022 Mycoplasma pneumonia 8 HIGH July 26, 1993
15775 22161 Gen-Probe M. pneumoniae Rapid Diagnostic System (including culture) 4022 Mycoplasma pneumonia 8 HIGH July 26, 1993
15776 7328 BioWhittaker FIAX System 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15777 7339 BioWhittaker MYCOPLASMELISA II 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15778 K931557 19021 Fuller Laboratories Mycoplasma pneumoniae IgG Antibody Kit 4016 Mycoplasma pneumoniae Antibodies 3 HIGH September 30, 1994
15780 K963055 22190 GenBio ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 18, 1997
15781 K963054 22189 GenBio ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 18, 1997
15782 28044 Incstar IgM-MP Reverse ELISA Kit 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15783 28047 Incstar Mp Test IgM/IgG MA Reverse ELISA Kit 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15788 58041 Seradyn Color Vue - Mycoplasma pneumonia 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15789 K920212 58287 Shared Systems M. pneumoniae Antibody EIA Test System 4016 Mycoplasma pneumoniae Antibodies 3 HIGH November 22, 1993
15794 K971393 70220 Wampole Mycoplasma IgG ELISA 4016 Mycoplasma pneumoniae Antibodies 3 HIGH May 15, 1998
15795 79019 Zeus Scientific MP IgG IFA 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15796 79020 Zeus Scientific MP IgM IFA 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
15797 K970150 79056 Zeus Scientific Mycoplasma IgG ELISA 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 25, 1997
15798 K971503 79059 Zeus Scientific Mycoplasma IgM ELISA 4016 Mycoplasma pneumoniae Antibodies 3 HIGH September 11, 1998
15809 7256 Biomerica RIA Test Kit 4023 Myoglobin 2 HIGH July 26, 1993
15825 28232 ImmunoDiagnosticCenter Myoglobin ELISA Test Kit 4023 Myoglobin 2 HIGH July 26, 1993
15855 4275 Ames OPTIMATE 4301 N-Acetylprocainamide (NAPA) 7 HIGH July 26, 1993
15856 4156 Ames TDA 4301 N-Acetylprocainamide (NAPA) 7 HIGH July 26, 1993
15894 28184 Instrumentation Laboratory Multistat III Plus 4301 N-Acetylprocainamide (NAPA) 7 HIGH July 26, 1993
15917 58082 Syva Emit Test Kit 4301 N-Acetylprocainamide (NAPA) 7 HIGH July 26, 1993
15925 K940979 22171 Gen-Probe PACE 2C System 4317 N. gonorrhoeae (from urogenital or rectal only) 8 HIGH November 10, 1994
15926 K920301 22041 Gen-Probe Pace2 (direct Ag) 4317 N. gonorrhoeae (from urogenital or rectal only) 8 HIGH July 26, 1993
15932 K935833 4545 Abbott LCx Neisseria gonorrhoeae Assay 4302 Neisseria gonorrhoeae 8 HIGH May 10, 1996
15933 4088 Adams Scientific Identicult - Neisseria (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15934 7033 Baxter Bartels N. gonorrhoeae DF (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15936 13158 Difco FA N. gonorrhoeae (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15937 K934125 16027 E-Y Laboratories Gonochek-II Kit 4302 Neisseria gonorrhoeae 8 HIGH October 14, 1994
15938 22040 Gen-Probe AccuProbe (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15939 28048 Incstar N. gonorrhoeae Fluoro-Kit (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15940 34006 Karobio Phadebact Monoclonal Gonococcus (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15941 40068 Meridian Diagnostics Meritec-GC (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15942 43003 New Horizons Gonogen (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15943 43004 New Horizons Gonogen II (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15944 K974342 55253 Roche Diagnostics COBAS AMPLICOR Analyzer 4302 Neisseria gonorrhoeae 8 HIGH January 7, 2000
15945 58097 Syva MicroTrak N. gonorrhoeae Culture Confirmation (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
15946 13155 Difco FA Meningococcus Poly (direct Ag) 4314 Neisseria meningitidis 8 HIGH July 26, 1993
15948 13223 Difco Bacto Neisseria Meningitidis Set (including culture) 4303 Neisseria meningitidis (non-specific) 8 HIGH July 26, 1993
15949 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 4304 Neisseria meningitidis, group A 8 HIGH June 7, 1996
15950 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 4304 Neisseria meningitidis, group A 8 HIGH July 26, 1993
15952 K952791 7727 Becton Dickinson Directigen Neisseria Meningitis (including culture) 4304 Neisseria meningitidis, group A 8 HIGH June 7, 1996
15953 7262 Becton Dickinson N. Meningitidis Test (blood culture supernatant) 4304 Neisseria meningitidis, group A 8 HIGH July 26, 1993
15955 13223 Difco Bacto Neisseria Meningitidis Set (including culture) 4304 Neisseria meningitidis, group A 8 HIGH July 26, 1993
15958 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 4304 Neisseria meningitidis, group A 8 HIGH July 26, 1993
15960 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 4304 Neisseria meningitidis, group A 8 HIGH July 26, 1993
15961 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 4306 Neisseria meningitidis, group B 8 HIGH June 7, 1996
15962 13223 Difco Bacto Neisseria Meningitidis Set (including culture) 4306 Neisseria meningitidis, group B 8 HIGH July 26, 1993
15964 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 4306 Neisseria meningitidis, group B 8 HIGH July 26, 1993
15966 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 4307 Neisseria meningitidis, group B and E. coli K1 8 HIGH July 26, 1993
15968 7261 Becton Dickinson Directigen Meningitis Indiv.Kit (blood culture supernatant) 4307 Neisseria meningitidis, group B and E. coli K1 8 HIGH July 26, 1993
15971 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 4307 Neisseria meningitidis, group B and E. coli K1 8 HIGH July 26, 1993
15973 70088 Wellcome Wellcogen Bacterial Ag Kit (including culture) 4307 Neisseria meningitidis, group B and E. coli K1 8 HIGH July 26, 1993
15974 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 4308 Neisseria meningitidis, group C 8 HIGH June 7, 1996
15975 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 4308 Neisseria meningitidis, group C 8 HIGH July 26, 1993
15976 K952791 7727 Becton Dickinson Directigen Neisseria Meningitis (including culture) 4308 Neisseria meningitidis, group C 8 HIGH June 7, 1996
15977 7262 Becton Dickinson N. Meningitidis Test (blood culture supernatant) 4308 Neisseria meningitidis, group C 8 HIGH July 26, 1993
15979 13223 Difco Bacto Neisseria Meningitidis Set (including culture) 4308 Neisseria meningitidis, group C 8 HIGH July 26, 1993
15982 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 4308 Neisseria meningitidis, group C 8 HIGH July 26, 1993
15984 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 4308 Neisseria meningitidis, group C 8 HIGH July 26, 1993
15986 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 4311 Neisseria meningitidis, group W135 8 HIGH July 26, 1993
15987 K952791 7727 Becton Dickinson Directigen Neisseria Meningitis (including culture) 4311 Neisseria meningitidis, group W135 8 HIGH June 7, 1996
15988 7262 Becton Dickinson N. Meningitidis Test (blood culture supernatant) 4311 Neisseria meningitidis, group W135 8 HIGH July 26, 1993
15990 13223 Difco Bacto Neisseria Meningitidis Set (including culture) 4311 Neisseria meningitidis, group W135 8 HIGH July 26, 1993
15991 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 4311 Neisseria meningitidis, group W135 8 HIGH July 26, 1993
15994 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 4311 Neisseria meningitidis, group W135 8 HIGH July 26, 1993
15995 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 4312 Neisseria meningitidis, group Y 8 HIGH June 7, 1996
15996 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 4312 Neisseria meningitidis, group Y 8 HIGH July 26, 1993
15999 7262 Becton Dickinson N. Meningitidis Test (blood culture supernatant) 4312 Neisseria meningitidis, group Y 8 HIGH July 26, 1993
16002 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 4312 Neisseria meningitidis, group Y 8 HIGH July 26, 1993
16004 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 4312 Neisseria meningitidis, group Y 8 HIGH July 26, 1993
16007 4275 Ames OPTIMATE 4313 Netilmycin 7 HIGH July 26, 1993
16017 E990014 34110 KMI Diagnostics 125 I-Noradrenalin (125 I-Norepinephrine) RIA 4323 Norepinephrine (Noradrenalin) 6 HIGH April 2, 1999
16018 E990016 34106 KMI Diagnostics KatCombi 4323 Norepinephrine (Noradrenalin) 6 HIGH April 2, 1999
16019 E990017 34112 KMI Diagnostics Noradrenalin (Norepinephrine) ELISA 4323 Norepinephrine (Noradrenalin) 6 HIGH April 2, 1999
16020 E990015 34109 KMI Diagnostics TriCat 4323 Norepinephrine (Noradrenalin) 6 HIGH April 2, 1999
16021 P940035 40305 Matritech NMP22 Test (auto calculations) 4322 Nuclear Matrix Protein 22 (NMP22) 2 HIGH August 28, 1998
16022 P940035 40303 Matritech NMP22 Test (manual calculations) 4322 Nuclear Matrix Protein 22 (NMP22) 2 HIGH August 28, 1998
16023 K945519 22181 Glyco FACE Qualitative Urinary Carbohydrate Analysis Kit 4607 Oligosaccharides, Urinary 2 HIGH March 15, 1996
16036 4275 Ames OPTIMATE 4601 Opiates 7 HIGH July 26, 1993
16039 K945343 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16047 K945343 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16052 K945343 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH April 10, 1998
16063 K935346 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16068 K935346 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16076 K945343 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16079 K945343 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16095 13030 Diagnostic Products Corp. Coat-A-Count 4601 Opiates 7 HIGH July 26, 1993
16096 13111 Diagnostic Products Corp. Milenia 4601 Opiates 7 HIGH July 26, 1993
16109 19013 Finnigan MAT Witness System 4601 Opiates 7 HIGH July 26, 1993
16110 28175 Immunotech Microzyme EIA (spectrophotometric) 4601 Opiates 7 HIGH July 26, 1993
16115 28184 Instrumentation Laboratory Multistat III Plus 4601 Opiates 7 HIGH July 26, 1993
16127 K945207 40233 Meco Industries MECTEST Opiate Radioimmunoassay 4601 Opiates 7 HIGH October 27, 1995
16129 K923468 40168 Microdiagnostics Micro EIA Opiate Metabolites 4601 Opiates 7 HIGH November 22, 1993
16132 K945343 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
16174 K935346 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH May 7, 1999
16177 K935346 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH May 7, 1999
16180 K945343 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH May 7, 1999
16183 K945343 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH May 7, 1999
16186 K935565 58380 STC Technologies Opiates M-Plate EIA {Sudormed Patch} 4601 Opiates 7 HIGH September 8, 1995
16187 K981341 58522 STC Technologies Opiates Micro-Plate EIA {EpiScreen Oral Fluid Specimens} 4601 Opiates 7 HIGH July 10, 1998
16188 58106 Sigma Diagnostics SIA Opiate 4601 Opiates 7 HIGH July 26, 1993
16196 58188 Syva Emit st Drug Detection System 4601 Opiates 7 HIGH July 26, 1993
16197 58190 Syva Qstat/Qst System 4601 Opiates 7 HIGH July 26, 1993
16198 61063 TOXI-LAB Opiate Procedure 4601 Opiates 7 HIGH July 26, 1993
16203 K931227 64026 USDT Flow Immunoassay System 4601 Opiates 7 HIGH January 21, 1994
16204 K973155 64042 United Biotech UBI MAGIWEL ELISA for Opiate Metabolites 4601 Opiates 7 HIGH April 10, 1998
16285 4035 Abbott Bichromatic ABA 100 4605 Oxalate 2 HIGH July 26, 1993
16286 4036 Abbott Bichromatic ABA 200 4605 Oxalate 2 HIGH July 26, 1993
16287 4067 Abbott Spectrum 4605 Oxalate 2 HIGH July 26, 1993
16288 7071 Beckman Synchron CX 4 4605 Oxalate 2 HIGH July 26, 1993
16289 7072 Beckman Synchron CX 5 4605 Oxalate 2 HIGH July 26, 1993
16290 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 4605 Oxalate 2 HIGH July 26, 1993
16291 7161 Boehringer Mannheim Hitachi 704 4605 Oxalate 2 HIGH July 26, 1993
16292 7162 Boehringer Mannheim Hitachi 705 4605 Oxalate 2 HIGH July 26, 1993
16293 7163 Boehringer Mannheim Hitachi 717 4605 Oxalate 2 HIGH July 26, 1993
16294 7164 Boehringer Mannheim Hitachi 736 4605 Oxalate 2 HIGH July 26, 1993
16295 10352 Chiron Diagnostics 550 Express 4605 Oxalate 2 HIGH November 15, 1996
16296 10038 Ciba Corning 550 Express 4605 Oxalate 2 HIGH July 26, 1993
16297 10106 Coulter Dacos 4605 Oxalate 2 HIGH July 26, 1993
16298 16015 EM Diagnostic Systems EPOS 4605 Oxalate 2 HIGH July 26, 1993
16299 16010 Electronucleonics FLEXIGEM 4605 Oxalate 2 HIGH July 26, 1993
16300 16005 Electronucleonics Gemini 4605 Oxalate 2 HIGH July 26, 1993
16301 16006 Electronucleonics Gemstar 4605 Oxalate 2 HIGH July 26, 1993
16302 28082 Instrumentation Laboratory IL Monarch 1000 4605 Oxalate 2 HIGH July 26, 1993
16303 28231 Instrumentation Laboratory IL Monarch 2000 4605 Oxalate 2 HIGH July 26, 1993
16304 46089 Olympus Reply 4605 Oxalate 2 HIGH July 26, 1993
16305 46129 Olympus Reply/AU 560 4605 Oxalate 2 HIGH July 26, 1993
16306 55100 Roche Diagnostics Cobas Bio 4605 Oxalate 2 HIGH July 26, 1993
16307 55040 Roche Diagnostics Cobas FARA 4605 Oxalate 2 HIGH July 26, 1993
16308 55041 Roche Diagnostics Cobas FARA II 4605 Oxalate 2 HIGH July 26, 1993
16309 55044 Roche Diagnostics Cobas Mira 4605 Oxalate 2 HIGH July 26, 1993
16310 55367 Roche Diagnostics Hitachi 704 4605 Oxalate 2 HIGH May 7, 1999
16311 55401 Roche Diagnostics Hitachi 717 4605 Oxalate 2 HIGH May 7, 1999
16312 55451 Roche Diagnostics Hitachi 736 4605 Oxalate 2 HIGH May 7, 1999
16313 58051 Sigma Diagnostics Test Kit 4605 Oxalate 2 HIGH July 26, 1993
16314 61010 Technicon RA 1000 4605 Oxalate 2 HIGH July 26, 1993
16315 61011 Technicon RA 2000 4605 Oxalate 2 HIGH July 26, 1993
16316 61012 Technicon RA 500 4605 Oxalate 2 HIGH July 26, 1993
16317 61013 Technicon RA XT 4605 Oxalate 2 HIGH July 26, 1993
16376 10341 Chiron Diagnostics 168 4983 PCO2 2 HIGH November 15, 1996
16390 10031 Ciba Corning 158 4983 PCO2 2 HIGH July 26, 1993
16481 10340 Chiron Diagnostics 158 4984 PO2 2 HIGH November 15, 1996
16482 10341 Chiron Diagnostics 168 4984 PO2 2 HIGH November 15, 1996
16496 10031 Ciba Corning 158 4984 PO2 2 HIGH July 26, 1993
16497 10032 Ciba Corning 168 4984 PO2 2 HIGH July 26, 1993
16579 7035 Baxter Bartels Viral Respiratory Kit (direct Ag) 4959 Parainfluenza 1 10 HIGH September 1, 1994
16580 K943557 13373 DAKO IMAGEN Parainfluenza virus Group (including cell culture) 4959 Parainfluenza 1 10 HIGH February 17, 1995
16581 K943557 13374 DAKO IMAGEN Parainfluenza virus Types 1,2,3 (including cell culture) 4959 Parainfluenza 1 10 HIGH February 17, 1995
16582 K871234 28599 INTRACEL Bartels Viral Respiratory Kit (direct Ag) 4959 Parainfluenza 1 10 HIGH January 18, 2000
16583 K871234 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 4959 Parainfluenza 1 10 HIGH January 18, 2000
16584 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 4959 Parainfluenza 1 10 HIGH November 22, 1993
16585 K933575 58315 Symex ViraSTAT Anti-Parainfluenza MAbs 4959 Parainfluenza 1 10 HIGH January 6, 1995
16586 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 4959 Parainfluenza 1 10 HIGH June 21, 1996
16587 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 4960 Parainfluenza 2 10 HIGH September 1, 1994
16588 K943557 13373 DAKO IMAGEN Parainfluenza virus Group (including cell culture) 4960 Parainfluenza 2 10 HIGH February 17, 1995
16589 K943557 13374 DAKO IMAGEN Parainfluenza virus Types 1,2,3 (including cell culture) 4960 Parainfluenza 2 10 HIGH February 17, 1995
16590 K871234 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 4960 Parainfluenza 2 10 HIGH January 18, 2000
16591 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 4960 Parainfluenza 2 10 HIGH November 22, 1993
16592 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 4960 Parainfluenza 2 10 HIGH June 21, 1996
16593 7035 Baxter Bartels Viral Respiratory Kit (direct Ag) 4961 Parainfluenza 3 10 HIGH September 1, 1994
16594 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 4961 Parainfluenza 3 10 HIGH September 1, 1994
16595 K943557 13373 DAKO IMAGEN Parainfluenza virus Group (including cell culture) 4961 Parainfluenza 3 10 HIGH February 17, 1995
16596 K943557 13374 DAKO IMAGEN Parainfluenza virus Types 1,2,3 (including cell culture) 4961 Parainfluenza 3 10 HIGH February 17, 1995
16597 K871234 28599 INTRACEL Bartels Viral Respiratory Kit (direct Ag) 4961 Parainfluenza 3 10 HIGH January 18, 2000
16598 K871234 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 4961 Parainfluenza 3 10 HIGH January 18, 2000
16599 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 4961 Parainfluenza 3 10 HIGH November 22, 1993
16600 K933575 58315 Symex ViraSTAT Anti-Parainfluenza MAbs 4961 Parainfluenza 3 10 HIGH January 6, 1995
16601 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 4961 Parainfluenza 3 10 HIGH June 21, 1996
16602 K950838 79047 ZymeTx ViraZyme Culture Confirmation Screen (including cell culture) 4975 Parainfluenza 4 10 HIGH June 21, 1996
16603 13188 Diagnostic Systems C-Parathyroid Hormone RIA Kit 4934 Parathyroid Hormone - C-Terminal 6 HIGH July 26, 1993
16604 28209 Incstar C-terminal PTH 4934 Parathyroid Hormone - C-Terminal 6 HIGH July 26, 1993
16605 K974306 4860 Alfa Scientific Designs Intact-PTH (Parathyroid Hormone) ELISA 4924 Parathyroid Hormone - Intact 6 HIGH July 23, 1999
16606 K921949 7138 Bio-Rad CoTube 4924 Parathyroid Hormone - Intact 6 HIGH November 22, 1993
16607 K950211 10299 CIS-US ELSA-PTH 4924 Parathyroid Hormone - Intact 6 HIGH April 21, 1995
16608 10055 Ciba Corning Magic Lite 4924 Parathyroid Hormone - Intact 6 HIGH July 26, 1993
16611 K930008 13030 Diagnostic Products Corp. Coat-A-Count 4924 Parathyroid Hormone - Intact 6 HIGH November 22, 1993
16612 K952199 13402 Diagnostic Systems Active I-PTH ELISA Kit 4924 Parathyroid Hormone - Intact 6 HIGH September 8, 1995
16613 13178 Diagnostic Systems Active Intact Parathyroid Hormone 4924 Parathyroid Hormone - Intact 6 HIGH July 26, 1993
16614 K941878 28350 ImmunoDiagnostic Systems OCTEIA Intact PTH 4924 Parathyroid Hormone - Intact 6 HIGH November 10, 1994
16615 28208 Incstar N-tact PTH IRMA 4924 Parathyroid Hormone - Intact 6 HIGH July 26, 1993
16617 43008 Nichols Institute Allegro RIA 4924 Parathyroid Hormone - Intact 6 HIGH July 26, 1993
16618 43080 Nichols Institute Chemiluminescence PTH Assay 4924 Parathyroid Hormone - Intact 6 HIGH September 1, 1994
16619 55010 Ramco Laboratories RIA Test Kit 4924 Parathyroid Hormone - Intact 6 HIGH July 26, 1993
16622 K944788 58348 Scantibodies Laboratory Intact PTH Assay 4924 Parathyroid Hormone - Intact 6 HIGH July 28, 1995
16623 13031 Diagnostic Products Corp. Double Antibody 4925 Parathyroid Hormone - Mid-molecule (PTH-M) 6 HIGH July 26, 1993
16624 13196 Diagnostic Systems Mid-Molecule Parathyroid Hormone RIA Kit 4925 Parathyroid Hormone - Mid-molecule (PTH-M) 6 HIGH July 26, 1993
16625 28207 Incstar PTH-MM II 4925 Parathyroid Hormone - Mid-molecule (PTH-M) 6 HIGH July 26, 1993
16626 43044 Nichols Institute RIA Kit 4925 Parathyroid Hormone - Mid-molecule (PTH-M) 6 HIGH July 26, 1993
16636 4275 Ames OPTIMATE 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16641 K946059 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16646 K946059 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16651 K946059 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16655 K946059 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH April 10, 1998
16663 K946059 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16667 K946059 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16674 K946059 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16687 13030 Diagnostic Products Corp. Coat-A-Count 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16688 13111 Diagnostic Products Corp. Milenia 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16702 19013 Finnigan MAT Witness System 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16707 28175 Immunotech Microzyme EIA (spectrophotometric) 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16711 28183 Instrumentation Laboratory Multistat III 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16712 28184 Instrumentation Laboratory Multistat III Plus 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16720 K946059 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
16746 55098 Roche Diagnostics Abuscreen RIA 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16757 K946059 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH May 7, 1999
16760 K946059 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH May 7, 1999
16765 K946059 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH May 7, 1999
16768 K946059 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH May 7, 1999
16776 58259 STC Technologies PCP EIA Plate Kit 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16777 K940048 58406 STC Technologies PCP M-Plate EIA {Sudormed Patch} 4901 Phencyclidine (PCP) 7 HIGH April 12, 1996
16779 58107 Sigma Diagnostics SIA Phencyclidine 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16787 58188 Syva Emit st Drug Detection System 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16788 58190 Syva Qstat/Qst System 4901 Phencyclidine (PCP) 7 HIGH July 26, 1993
16795 K935629 64026 USDT Flow Immunoassay System 4901 Phencyclidine (PCP) 7 HIGH September 15, 1994
16800 4275 Ames OPTIMATE 4902 Phenobarbital 7 HIGH July 26, 1993
16802 4156 Ames TDA 4902 Phenobarbital 7 HIGH July 26, 1993
16810 7383 Beckman Auto ICS 4902 Phenobarbital 7 HIGH July 26, 1993
16811 7381 Beckman ICS 4902 Phenobarbital 7 HIGH July 26, 1993
16826 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 4902 Phenobarbital 7 HIGH July 26, 1993
16837 10060 Clinical Assays GammaCoat 4902 Phenobarbital 7 HIGH July 26, 1993
16861 28172 Immunotech ENDAB EIA Kit 4902 Phenobarbital 7 HIGH July 26, 1993
16867 28183 Instrumentation Laboratory Multistat III 4902 Phenobarbital 7 HIGH July 26, 1993
16868 28184 Instrumentation Laboratory Multistat III Plus 4902 Phenobarbital 7 HIGH July 26, 1993
16897 58082 Syva Emit Test Kit 4902 Phenobarbital 7 HIGH July 26, 1993
16898 58190 Syva Qstat/Qst System 4902 Phenobarbital 7 HIGH July 26, 1993
16905 K891070 4696 Astoria-Pacific API 300 SPOTCHECK System 4942 Phenylalanine 2 HIGH April 18, 1997
16906 K891070 4781 Astoria-Pacific SPOTCHECK Analyzer 4942 Phenylalanine 2 HIGH April 3, 1998
16907 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4942 Phenylalanine 2 HIGH December 9, 1994
16909 K926106 28384 ICN ImmuChem Phenylalanine Microwell Enzyme Assay 4942 Phenylalanine 2 HIGH March 10, 1995
16910 28183 Instrumentation Laboratory Multistat III 4942 Phenylalanine 2 HIGH July 26, 1993
16911 28184 Instrumentation Laboratory Multistat III Plus 4942 Phenylalanine 2 HIGH July 26, 1993
16912 K943547 28367 Isolab Fluoroscan II Neonatal Chemistry System 4942 Phenylalanine 2 HIGH February 2, 1996
16913 K974047 43126 Neometrics Accuwell Phenylalanine Assay 4942 Phenylalanine 2 HIGH October 9, 1998
16914 K922547 49125 Porton Cambridge Quantase Phenylalanine Assay 4942 Phenylalanine 2 HIGH December 9, 1994
16915 K984463 52111 Quantase Phe/Gal (Newborn) Screening Assay 4942 Phenylalanine 2 HIGH July 23, 1999
16916 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 4942 Phenylalanine 2 HIGH May 26, 1995
16921 4275 Ames OPTIMATE 4903 Phenytoin 7 HIGH July 26, 1993
16924 4156 Ames TDA 4903 Phenytoin 7 HIGH July 26, 1993
16932 7383 Beckman Auto ICS 4903 Phenytoin 7 HIGH July 26, 1993
16933 7381 Beckman ICS 4903 Phenytoin 7 HIGH July 26, 1993
16960 10060 Clinical Assays GammaCoat 4903 Phenytoin 7 HIGH July 26, 1993
16982 28173 Immunotech EZ-BEAD EIA Kit 4903 Phenytoin 7 HIGH July 26, 1993
16989 28183 Instrumentation Laboratory Multistat III 4903 Phenytoin 7 HIGH July 26, 1993
17010 K963840 55236 Roche Diagnostics Cobas Mira {CEDIA} (manual curve) 4903 Phenytoin 7 HIGH May 16, 1997
17023 58082 Syva Emit Test Kit 4903 Phenytoin 7 HIGH July 26, 1993
17024 58190 Syva Qstat/Qst System 4903 Phenytoin 7 HIGH July 26, 1993
17038 58082 Syva Emit Test Kit 4904 Phenytoin, Free 7 HIGH July 26, 1993
17040 28194 Isolab PG - Numeric 4905 Phosphatidylglycerol (PG) - Amniotic Fluid 2 HIGH July 26, 1993
17041 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4970 Phosphoethanolamine 2 HIGH November 10, 1994
17042 58229 Sterling Diagnostics Analyzer 2000 4937 Phospholipids 2 HIGH July 26, 1993
17043 70116 Wako Phospholipids Test Kit 4937 Phospholipids 2 HIGH July 26, 1993
17046 4035 Abbott Bichromatic ABA 100 4906 Phosphorus 2 HIGH July 26, 1993
17047 4036 Abbott Bichromatic ABA 200 4906 Phosphorus 2 HIGH July 26, 1993
17048 4267 Abbott Bichromatic ABA 50 4906 Phosphorus 2 HIGH July 26, 1993
17058 4143 American Monitor KDA 4906 Phosphorus 2 HIGH July 26, 1993
17059 4144 American Monitor Parallel 4906 Phosphorus 2 HIGH July 26, 1993
17060 4275 Ames OPTIMATE 4906 Phosphorus 2 HIGH July 26, 1993
17099 13216 DMA Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17108 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 4906 Phosphorus 2 HIGH July 26, 1993
17120 16010 Electronucleonics FLEXIGEM 4906 Phosphorus 2 HIGH July 26, 1993
17126 K880676 25202 Horizon Inorganic Phosphorus (manual) 4906 Phosphorus 2 HIGH April 28, 1995
17133 28183 Instrumentation Laboratory Multistat III 4906 Phosphorus 2 HIGH July 26, 1993
17134 28184 Instrumentation Laboratory Multistat III Plus 4906 Phosphorus 2 HIGH July 26, 1993
17163 40126 Mallinckrodt Serometer 370 4906 Phosphorus 2 HIGH July 26, 1993
17164 40124 Medical Analysis Systems RefLab Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17165 40118 Meditech Diagnostic System Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17190 49064 Pointe Scientific 180 Chemistry Analyzer 4906 Phosphorus 2 HIGH July 26, 1993
17192 55075 Reagents Applications RAICHEM Test Kit (manual) 4906 Phosphorus 2 HIGH July 26, 1993
17213 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 4906 Phosphorus 2 HIGH July 26, 1993
17214 58186 Seragen Quick-Chem 4906 Phosphorus 2 HIGH July 26, 1993
17215 58164 Sherwood Medical Auto/Stat Kit 4906 Phosphorus 2 HIGH July 26, 1993
17216 58051 Sigma Diagnostics Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17217 58195 SmithKline ESKALAB-CCS 4906 Phosphorus 2 HIGH July 26, 1993
17218 58210 Stanbio Premiere 4906 Phosphorus 2 HIGH July 26, 1993
17219 58157 Stanbio Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17220 58229 Sterling Diagnostics Analyzer 2000 4906 Phosphorus 2 HIGH July 26, 1993
17221 58230 Sterling Diagnostics Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17224 K881171 61414 TECO Diagnostics Inorganic Phosphorus Reagent Set (manual) 4906 Phosphorus 2 HIGH March 26, 1999
17225 K882938 61377 TECO Diagnostics TC 84 4906 Phosphorus 2 HIGH November 19, 1998
17226 61044 TRACE Scientific Test Kit 4906 Phosphorus 2 HIGH July 26, 1993
17236 61014 Technicon SMA 12/60 4906 Phosphorus 2 HIGH July 26, 1993
17237 61016 Technicon SMAC 4906 Phosphorus 2 HIGH July 26, 1993
17238 61045 Technicon SMAC 2 4906 Phosphorus 2 HIGH July 26, 1993
17239 61046 Technicon SMAC 3 4906 Phosphorus 2 HIGH July 26, 1993
17243 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4969 Phosphoserine 2 HIGH November 10, 1994
17244 28183 Instrumentation Laboratory Multistat III 4940 Plasmin 4 HIGH July 26, 1993
17245 28184 Instrumentation Laboratory Multistat III Plus 4940 Plasmin 4 HIGH July 26, 1993
17246 K942117 4594 American Bioproducts STA Analyzer 4907 Plasminogen 4 HIGH February 17, 1995
17247 K961579 4677 American Bioproducts STA Compact Analyzer 4907 Plasminogen 4 HIGH November 1, 1996
17248 K983460 4875 American Bioproducts STA-R Analyzer 4907 Plasminogen 4 HIGH October 25, 1999
17249 4357 American Diagnostica Actichrome PLG 4907 Plasminogen 4 HIGH July 26, 1993
17250 K955278 7824 Behring Coagulation Timer (BCT) 4907 Plasminogen 4 HIGH November 15, 1996
17253 7193 Bio/Data PAP-4C 4907 Plasminogen 4 HIGH July 26, 1993
17255 K974711 10454 Chromogenix Coamatic Plasminogen (manual) 4907 Plasminogen 4 HIGH December 8, 1998
17256 K970431 13608 Dade Behring Coagulation System (BCS) 4907 Plasminogen 4 HIGH January 26, 2000
17260 13143 Diagnostica Stago Stachrom PLG 4907 Plasminogen 4 HIGH July 26, 1993
17267 K952669 25240 Helena Laboratories Chrom Z-PLG (manual) 4907 Plasminogen 4 HIGH December 15, 1995
17268 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 4907 Plasminogen 4 HIGH July 26, 1993
17269 K952669 25029 Helena Laboratories PACKS-4 4907 Plasminogen 4 HIGH December 15, 1995
17270 25005 Helena Laboratories Quiplate System for RID 4907 Plasminogen 4 HIGH July 26, 1993
17271 K981200 28073 Instrumentation Laboratory IL ACL 100 4907 Plasminogen 4 HIGH December 8, 1998
17272 K981200 28074 Instrumentation Laboratory IL ACL 1000 4907 Plasminogen 4 HIGH December 8, 1998
17273 28075 Instrumentation Laboratory IL ACL 200 4907 Plasminogen 4 HIGH July 26, 1993
17274 28076 Instrumentation Laboratory IL ACL 2000 4907 Plasminogen 4 HIGH July 26, 1993
17275 28077 Instrumentation Laboratory IL ACL 300 4907 Plasminogen 4 HIGH July 26, 1993
17276 K974711 28540 Instrumentation Laboratory IL ACL 300 {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17277 28197 Instrumentation Laboratory IL ACL 300 Plus 4907 Plasminogen 4 HIGH July 26, 1993
17278 28078 Instrumentation Laboratory IL ACL 3000 4907 Plasminogen 4 HIGH July 26, 1993
17279 28079 Instrumentation Laboratory IL ACL 3000 Plus 4907 Plasminogen 4 HIGH July 26, 1993
17280 K961991 28454 Instrumentation Laboratory IL ACL 6000 4907 Plasminogen 4 HIGH September 13, 1996
17281 28080 Instrumentation Laboratory IL ACL 810 4907 Plasminogen 4 HIGH July 26, 1993
17282 K981200 28395 Instrumentation Laboratory IL ACL Futura System 4907 Plasminogen 4 HIGH December 8, 1998
17283 40037 Medical Laboratory MLA Electra 1000 C 4907 Plasminogen 4 HIGH July 26, 1993
17284 K974711 40313 Medical Laboratory MLA Electra 1000C {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17285 K944227 40208 Medical Laboratory MLA Electra 1400C 4907 Plasminogen 4 HIGH April 7, 1995
17286 K931206 40167 Medical Laboratory MLA Electra 1600C 4907 Plasminogen 4 HIGH November 22, 1993
17287 K962664 40282 Medical Laboratory MLA Electra 1800C 4907 Plasminogen 4 HIGH December 5, 1997
17288 40042 Medical Laboratory MLA Electra 900C 4907 Plasminogen 4 HIGH July 26, 1993
17289 K974711 40312 Medical Laboratory MLA Electra 900C {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17290 46092 Organon Teknika Chromostrate Plasminogen Assay 4907 Plasminogen 4 HIGH July 26, 1993
17291 46128 Ortho Koagulab CTS 4907 Plasminogen 4 HIGH July 26, 1993
17292 K974711 55308 Roche Diagnostics Cobas Bio {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17293 K974711 55309 Roche Diagnostics Cobas FARA {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17294 K974711 55307 Roche Diagnostics Cobas Mira {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
17296 K964139 58606 Sysmex CA-6000 4907 Plasminogen 4 HIGH January 27, 2000
17297 K964139 61283 TOA Medical Electronics CA-6000 4907 Plasminogen 4 HIGH April 11, 1997
17298 K941346 61159 The Binding Site Plasminogen RID 4907 Plasminogen 4 HIGH November 10, 1994
17299 K933188 7521 Baxter Plasminogen Activator Inhibitor-1 (PAI) 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH May 20, 1994
17300 K963106 7927 Biopool Chromolize PAI-1 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH August 8, 1997
17301 K922782 7482 Biopool Spectrolyse/pL PAI 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH November 22, 1993
17302 K960438 7787 Biopool TintElize PAI-1 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH July 19, 1996
17303 K933188 13491 Dade Plasminogen Activator Inhibitor-1 (PAI) 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH April 17, 1998
17304 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH July 26, 1993
17305 K944227 40208 Medical Laboratory MLA Electra 1400C 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH April 7, 1995
17306 K962664 40282 Medical Laboratory MLA Electra 1800C 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH December 5, 1997
17308 K954202 25243 HemoTec Hepcon HMS {Platelet Function Test} 4977 Platelet Activated Clot Ratio 4 HIGH June 28, 1996
17309 7194 Bio/Data PAP-4 4928 Platelet Aggregation 4 HIGH July 26, 1993
17310 7193 Bio/Data PAP-4C 4928 Platelet Aggregation 4 HIGH July 26, 1993
17312 10147 Chrono-log Aggregometer 400VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17313 10149 Chrono-log Aggregometer 430VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17314 10148 Chrono-log Aggregometer 460VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17315 10151 Chrono-log Aggregometer 470VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17316 10152 Chrono-log Aggregometer 500Ca 4928 Platelet Aggregation 4 HIGH July 26, 1993
17317 10154 Chrono-log Aggregometer 500VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17318 10155 Chrono-log Aggregometer 530VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17319 10156 Chrono-log Aggregometer 540VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17320 10153 Chrono-log Aggregometer 560Ca 4928 Platelet Aggregation 4 HIGH July 26, 1993
17321 10157 Chrono-log Aggregometer 560VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17322 10158 Chrono-log Aggregometer 570VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
17323 10144 Chrono-log P.I.C.A. 4928 Platelet Aggregation 4 HIGH July 26, 1993
17325 25029 Helena Laboratories PACKS-4 4928 Platelet Aggregation 4 HIGH July 26, 1993
17326 37012 Logos elvi 840 Aggregometer 4928 Platelet Aggregation 4 HIGH July 26, 1993
17327 58119 Sienco Dual Sample Aggregation Meter (DP-247) 4928 Platelet Aggregation 4 HIGH July 26, 1993
17329 28128 Immucor Capture-P 4927 Platelet Antibody - detection 3 HIGH July 26, 1993
17330 28089 Immucor MCP (Modified Capture-P) 4927 Platelet Antibody - detection 3 HIGH July 26, 1993
17352 4124 All Manual Platelet Count Test Systems and Procedures 4908 Platelet Count 4 HIGH July 26, 1993
17401 10182 Coulter Thrombocounter-C 4908 Platelet Count 4 HIGH July 26, 1993
17402 K952308 10325 Coulter Z1 4908 Platelet Count 4 HIGH November 3, 1995
17403 K991070 10479 Coulter Z2 Analyzer 4908 Platelet Count 4 HIGH July 9, 1999
17404 10126 Coulter ZBI 4908 Platelet Count 4 HIGH July 26, 1993
17405 10128 Coulter ZF 4908 Platelet Count 4 HIGH July 26, 1993
17406 10129 Coulter ZF5 4908 Platelet Count 4 HIGH July 26, 1993
17407 10130 Coulter ZM 4908 Platelet Count 4 HIGH July 26, 1993
17408 13283 DMA H10 4908 Platelet Count 4 HIGH September 1, 1994
17410 13282 DMA Plt-4 4908 Platelet Count 4 HIGH September 1, 1994
17431 40174 Mallinckrodt Plt-4 4908 Platelet Count 4 HIGH September 1, 1994
17459 58305 SmithKline ESKALAB-CHS H10 4908 Platelet Count 4 HIGH September 1, 1994
17497 61126 Texas International Laboratories Plt-4 4908 Platelet Count 4 HIGH September 1, 1994
17498 13130 Diagnostica Stago ASSERACHROM PF4 4931 Platelet Factor IV 4 HIGH July 26, 1993
17501 K905504 13376 DAKO Quick Staining Kit for Pneumocystis carinii 4926 Pneumocystis 11 HIGH April 7, 1995
17502 22066 Genetic Systems Pneumocystis carinii IFA Test Kit 4926 Pneumocystis 11 HIGH July 26, 1993
17503 K992252 37158 Light Diagnostics Pneumocystis carinii DFA 4926 Pneumocystis 11 HIGH November 1, 1999
17504 40097 Meridian Diagnostics MERIFLUOR Pneumocystis 4926 Pneumocystis 11 HIGH July 26, 1993
17505 K923349 49099 Polysciences Fungi-Fluor Pneumocystis 4926 Pneumocystis 11 HIGH November 22, 1993
17506 K960090 55206 Remel Calcofluor White Stain Kit 4926 Pneumocystis 11 HIGH May 17, 1996
17507 K940026 37083 Light Diagnostics MAb Poliovirus Blend (including culture) 4966 Poliovirus 1 10 HIGH September 15, 1995
17508 K940034 37081 Light Diagnostics MAb Poliovirus 2 (including culture) 4967 Poliovirus 2 10 HIGH September 15, 1995
17509 K940026 37083 Light Diagnostics MAb Poliovirus Blend (including culture) 4967 Poliovirus 2 10 HIGH September 15, 1995
17510 K940017 37082 Light Diagnostics MAb Poliovirus 3 (including culture) 4968 Poliovirus 3 10 HIGH September 15, 1995
17511 K940026 37083 Light Diagnostics MAb Poliovirus Blend (including culture) 4968 Poliovirus 3 10 HIGH September 15, 1995
17512 K961984 61276 Trace America Porphobilinogen (PBG) Test Kit 4939 Porphobilinogen 2 HIGH February 28, 1997
17513 70098 Whale Scientific Porphyrins and Porphobilinogen 4939 Porphobilinogen 2 HIGH July 26, 1993
17514 70098 Whale Scientific Porphyrins and Porphobilinogen 4938 Porphyrins 2 HIGH July 26, 1993
17536 4035 Abbott Bichromatic ABA 100 4910 Potassium 2 HIGH July 26, 1993
17537 4036 Abbott Bichromatic ABA 200 4910 Potassium 2 HIGH July 26, 1993
17538 4267 Abbott Bichromatic ABA 50 4910 Potassium 2 HIGH July 26, 1993
17564 7062 Beckman Flame Photometer 4910 Potassium 2 HIGH July 26, 1993
17595 7423 Boehringer Mannheim LyteTek Flame Photometer 4910 Potassium 2 HIGH July 26, 1993
17660 28158 Instrumentation Laboratory IL 508 4910 Potassium 2 HIGH July 26, 1993
17663 28081 Instrumentation Laboratory IL Flame Photometer/Elect 4910 Potassium 2 HIGH July 26, 1993
17706 40126 Mallinckrodt Serometer 370 4910 Potassium 2 HIGH July 26, 1993
17775 49064 Pointe Scientific 180 Chemistry Analyzer 4910 Potassium 2 HIGH July 26, 1993
17809 55577 Roche Diagnostics LyteTek Flame Photometer 4910 Potassium 2 HIGH May 7, 1999
17814 58195 SmithKline ESKALAB-CCS 4910 Potassium 2 HIGH July 26, 1993
17815 58210 Stanbio Premiere 4910 Potassium 2 HIGH July 26, 1993
17817 58230 Sterling Diagnostics Test Kit 4910 Potassium 2 HIGH July 26, 1993
17819 K902574 61418 TECO Diagnostics Potassium Reagent Set (manual) 4910 Potassium 2 HIGH March 26, 1999
17820 K882938 61377 TECO Diagnostics TC 84 4910 Potassium 2 HIGH November 19, 1998
17831 61015 Technicon SMA 6/60 4910 Potassium 2 HIGH July 26, 1993
17832 61016 Technicon SMAC 4910 Potassium 2 HIGH July 26, 1993
17833 61046 Technicon SMAC 3 4910 Potassium 2 HIGH July 26, 1993
17840 7383 Beckman Auto ICS 4911 Prealbumin 2 HIGH July 26, 1993
17841 7381 Beckman ICS 4911 Prealbumin 2 HIGH July 26, 1993
17842 7382 Beckman ICS II 4911 Prealbumin 2 HIGH July 26, 1993
17848 7118 Behring M-partigen Kit 4911 Prealbumin 2 HIGH July 26, 1993
17864 28183 Instrumentation Laboratory Multistat III 4911 Prealbumin 2 HIGH July 26, 1993
17865 34010 Kent Radial Immunodiffusion Test 4911 Prealbumin 2 HIGH July 26, 1993
17868 K972812 55284 RAIChem Prealbumin SPIA 4911 Prealbumin 2 HIGH February 6, 1998
17879 61083 The Binding Site Human Prealbumin RID 4911 Prealbumin 2 HIGH July 26, 1993
17881 4275 Ames OPTIMATE 4912 Primidone 7 HIGH July 26, 1993
17882 4156 Ames TDA 4912 Primidone 7 HIGH July 26, 1993
17885 7383 Beckman Auto ICS 4912 Primidone 7 HIGH July 26, 1993
17886 7381 Beckman ICS 4912 Primidone 7 HIGH July 26, 1993
17887 7382 Beckman ICS II 4912 Primidone 7 HIGH July 26, 1993
17914 28183 Instrumentation Laboratory Multistat III 4912 Primidone 7 HIGH July 26, 1993
17915 28184 Instrumentation Laboratory Multistat III Plus 4912 Primidone 7 HIGH July 26, 1993
17936 58082 Syva Emit Test Kit 4912 Primidone 7 HIGH July 26, 1993
17937 58190 Syva Qstat/Qst System 4912 Primidone 7 HIGH July 26, 1993
17943 4275 Ames OPTIMATE 4913 Procainamide 7 HIGH July 26, 1993
17980 28183 Instrumentation Laboratory Multistat III 4913 Procainamide 7 HIGH July 26, 1993
17981 28184 Instrumentation Laboratory Multistat III Plus 4913 Procainamide 7 HIGH July 26, 1993
17996 K962099 55236 Roche Diagnostics Cobas Mira {CEDIA} (manual curve) 4913 Procainamide 7 HIGH May 16, 1997
18008 58082 Syva Emit Test Kit 4913 Procainamide 7 HIGH July 26, 1993
18014 E990037 4865 Alfa Scientific Designs Microwell Progesterone EIA 4914 Progesterone 6 HIGH August 12, 1999
18016 4148 Amersham Amerlite 4914 Progesterone 6 HIGH July 26, 1993
18026 7256 Biomerica RIA Test Kit 4914 Progesterone 6 HIGH July 26, 1993
18038 K923410 10261 CyberFluor FIAgen Progesterone Assay Kit 4914 Progesterone 6 HIGH November 10, 1994
18040 13030 Diagnostic Products Corp. Coat-A-Count 4914 Progesterone 6 HIGH July 26, 1993
18041 13111 Diagnostic Products Corp. Milenia 4914 Progesterone 6 HIGH July 26, 1993
18042 13201 Diagnostic Systems Active Progesterone RIA Kit 4914 Progesterone 6 HIGH July 26, 1993
18043 13200 Diagnostic Systems Progesterone RIA Kit 4914 Progesterone 6 HIGH July 26, 1993
18044 K931228 28325 Immunotech Progesterone RIA Kit 4914 Progesterone 6 HIGH June 10, 1994
18046 K973898 34103 KMI Diagnostics Progesterone ELISA 4914 Progesterone 6 HIGH March 26, 1999
18047 37029 Leeco Diagnostics RIA Test Kit 4914 Progesterone 6 HIGH July 26, 1993
18056 58091 Serono Baker Serozyme 4914 Progesterone 6 HIGH July 26, 1993
18058 58251 Serono Diagnostics Serozyme 4914 Progesterone 6 HIGH July 26, 1993
18066 K933128 16046 elias usa Synelisa Progesterone 4914 Progesterone 6 HIGH May 20, 1994
18071 4061 Abbott RIA Bead 4915 Prolactin 6 HIGH September 1, 1994
18072 K971921 4867 Alfa Scientific Designs Prolactin Hormone (PRL) ELISA 4915 Prolactin 6 HIGH August 12, 1999
18074 4148 Amersham Amerlite 4915 Prolactin 6 HIGH July 26, 1993
18083 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 4915 Prolactin 6 HIGH July 26, 1993
18094 10061 Clinical Assays GammaDab 4915 Prolactin 6 HIGH July 26, 1993
18101 13109 Diagnostic Products Corp. Coat-A-Count IRMA 4915 Prolactin 6 HIGH July 26, 1993
18102 13031 Diagnostic Products Corp. Double Antibody 4915 Prolactin 6 HIGH July 26, 1993
18103 13111 Diagnostic Products Corp. Milenia 4915 Prolactin 6 HIGH July 26, 1993
18104 K960060 13414 Diagnostic Systems DSL 4500 ACTIVE Prolactin Ctd-Tube IRMA 4915 Prolactin 6 HIGH April 12, 1996
18110 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 4915 Prolactin 6 HIGH July 26, 1993
18111 25053 Hybritech Photon Immunoassay Analyzer 4915 Prolactin 6 HIGH July 26, 1993
18112 25023 Hybritech Tandem-R 4915 Prolactin 6 HIGH July 26, 1993
18113 28174 Immunotech EZ-TUBE EIA Kit 4915 Prolactin 6 HIGH July 26, 1993
18114 K922170 31016 Johnson & Johnson CDL Amerlite Analyzer 4915 Prolactin 6 HIGH August 18, 1995
18116 37029 Leeco Diagnostics RIA Test Kit 4915 Prolactin 6 HIGH July 26, 1993
18117 40117 Medix Biotech EIA Test Kit 4915 Prolactin 6 HIGH July 26, 1993
18118 K971921 40288 Monobind Prolactin Hormone (PRL) Microplate ELISA 4915 Prolactin 6 HIGH February 20, 1998
18119 43008 Nichols Institute Allegro RIA 4915 Prolactin 6 HIGH July 26, 1993
18120 43069 Nichols Institute Chemiluminescence Prolactin Assay 4915 Prolactin 6 HIGH September 1, 1994
18121 46007 Organon NML IRMA Test Kit 4915 Prolactin 6 HIGH July 26, 1993
18127 K930305 55122 Roche Diagnostics Cobas Core Prolactin EIA (manual) 4915 Prolactin 6 HIGH November 22, 1993
18133 K970188 58438 SeaLite Sciences AquaLite Prolactin (computer calculations) 4915 Prolactin 6 HIGH March 7, 1997
18135 58091 Serono Baker Serozyme 4915 Prolactin 6 HIGH July 26, 1993
18137 58251 Serono Diagnostics Serozyme 4915 Prolactin 6 HIGH July 26, 1993
18145 70152 Wallac Oy DELFIA Prolactin Kit 4915 Prolactin 6 HIGH September 1, 1994
18147 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4971 Proline 2 HIGH November 10, 1994
18150 7383 Beckman Auto ICS 4916 Properdin Factor B 3 HIGH July 26, 1993
18151 7381 Beckman ICS 4916 Properdin Factor B 3 HIGH July 26, 1993
18152 7382 Beckman ICS II 4916 Properdin Factor B 3 HIGH July 26, 1993
18154 34010 Kent Radial Immunodiffusion Test 4916 Properdin Factor B 3 HIGH July 26, 1993
18159 4275 Ames OPTIMATE 4917 Propoxyphene 7 HIGH July 26, 1993
18162 K951133 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18165 K951133 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18169 K951133 7724 Beckman Synchron CX 7 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18173 K951133 8078 Beckman Synchron LX System {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH April 10, 1998
18176 K951133 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18180 K951133 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18185 K951133 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18187 K951133 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH December 1, 1995
18219 K951133 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH May 7, 1999
18222 K951133 55409 Roche Diagnostics Hitachi 717 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH May 7, 1999
18227 K951133 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH May 7, 1999
18229 K951133 55521 Roche Diagnostics Hitachi 911 {CEDIA DAU} (manual curve) 4917 Propoxyphene 7 HIGH May 7, 1999
18241 4058 Abbott PAP EIA 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18243 7256 Biomerica RIA Test Kit 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18248 10061 Clinical Assays GammaDab 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18251 13109 Diagnostic Products Corp. Coat-A-Count IRMA 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18252 13111 Diagnostic Products Corp. Milenia 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18253 13091 Du Pont RIANEN RIA Kit 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18254 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18255 25053 Hybritech Photon Immunoassay Analyzer 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18256 25022 Hybritech Tandem-E 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18257 25023 Hybritech Tandem-R 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18259 37029 Leeco Diagnostics RIA Test Kit 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18265 58051 Sigma Diagnostics Test Kit 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18271 K981573 64049 United Biotech UBI MAGIWEL ELISA for PAP 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH November 6, 1998
18272 K964756 70199 Wano-Tech WANO-ASSAY IIA PAP (manual) 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH August 22, 1997
18273 76001 Yang Laboratories RIA 4918 Prostatic Acid Phosphatase (PAP) 2 HIGH July 26, 1993
18304 25022 Hybritech Tandem-E 4919 Prostatic Specific Antigen (PSA) 2 HIGH July 26, 1993
18305 25023 Hybritech Tandem-R 4919 Prostatic Specific Antigen (PSA) 2 HIGH July 26, 1993
18319 28094 ITC HEMOCHRON 400 4945 Protamine Response Test (PRT) 4 HIGH July 26, 1993
18320 28096 ITC HEMOCHRON 800 4945 Protamine Response Test (PRT) 4 HIGH July 26, 1993
18321 K930068 28298 ITC HEMOCHRON 8000 4945 Protamine Response Test (PRT) 4 HIGH November 22, 1993
18322 28097 ITC HEMOCHRON 801 4945 Protamine Response Test (PRT) 4 HIGH July 26, 1993
18323 K983475 28578 ITC HEMOCHRON Response 4945 Protamine Response Test (PRT) 4 HIGH January 31, 2000
18324 K904297 4728 American Bioproducts ST4 BIO 4929 Protein C 4 HIGH June 20, 1997
18325 K961579 4677 American Bioproducts STA Compact Analyzer 4929 Protein C 4 HIGH November 1, 1996
18326 K983460 4875 American Bioproducts STA-R Analyzer 4929 Protein C 4 HIGH October 25, 1999
18327 4359 American Diagnostica Rellplate C 4929 Protein C 4 HIGH July 26, 1993
18328 K955278 7824 Behring Coagulation Timer (BCT) 4929 Protein C 4 HIGH November 15, 1996
18329 K924425 7516 Behring Fibrintimer A 4929 Protein C 4 HIGH February 3, 1995
18330 7193 Bio/Data PAP-4C 4929 Protein C 4 HIGH July 26, 1993
18331 7219 Biopool Protein C EID Kit 4929 Protein C 4 HIGH July 26, 1993
18332 7218 Biopool Spectrolyse Protein C 4929 Protein C 4 HIGH July 26, 1993
18333 K922201 7161 Boehringer Mannheim Hitachi 704 4929 Protein C 4 HIGH November 22, 1993
18334 K922201 7162 Boehringer Mannheim Hitachi 705 4929 Protein C 4 HIGH November 22, 1993
18335 K922201 7163 Boehringer Mannheim Hitachi 717 4929 Protein C 4 HIGH November 22, 1993
18336 K970431 13608 Dade Behring Coagulation System (BCS) 4929 Protein C 4 HIGH January 26, 2000
18337 K992423 13548 Dade Behring Sysmex CA-500 Series 4929 Protein C 4 HIGH January 18, 2000
18338 13129 Diagnostica Stago ASSERACHROM Protein C 4929 Protein C 4 HIGH July 26, 1993
18339 13141 Diagnostica Stago Assera-Plate Protein C 4929 Protein C 4 HIGH July 26, 1993
18340 13218 Diagnostica Stago ST4 4929 Protein C 4 HIGH July 26, 1993
18341 13145 Diagnostica Stago Stachrom Protein C 4929 Protein C 4 HIGH July 26, 1993
18342 K952666 25237 Helena Laboratories Chrom Z-Protein C (manual) 4929 Protein C 4 HIGH February 2, 1996
18343 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 4929 Protein C 4 HIGH July 26, 1993
18344 K952666 25029 Helena Laboratories PACKS-4 4929 Protein C 4 HIGH February 2, 1996
18345 28073 Instrumentation Laboratory IL ACL 100 4929 Protein C 4 HIGH July 26, 1993
18346 28074 Instrumentation Laboratory IL ACL 1000 4929 Protein C 4 HIGH July 26, 1993
18347 28075 Instrumentation Laboratory IL ACL 200 4929 Protein C 4 HIGH July 26, 1993
18348 28076 Instrumentation Laboratory IL ACL 2000 4929 Protein C 4 HIGH July 26, 1993
18349 28077 Instrumentation Laboratory IL ACL 300 4929 Protein C 4 HIGH July 26, 1993
18350 28197 Instrumentation Laboratory IL ACL 300 Plus 4929 Protein C 4 HIGH July 26, 1993
18351 28078 Instrumentation Laboratory IL ACL 3000 4929 Protein C 4 HIGH July 26, 1993
18352 28079 Instrumentation Laboratory IL ACL 3000 Plus 4929 Protein C 4 HIGH July 26, 1993
18353 K961991 28454 Instrumentation Laboratory IL ACL 6000 4929 Protein C 4 HIGH September 13, 1996
18354 K961991 28487 Instrumentation Laboratory IL ACL 7000 4929 Protein C 4 HIGH September 19, 1997
18355 37034 LAbor COA Data 2000 4929 Protein C 4 HIGH July 26, 1993
18356 37066 LAbor COA Data 3000 4929 Protein C 4 HIGH July 26, 1993
18357 37035 LAbor COA System 4929 Protein C 4 HIGH July 26, 1993
18358 40037 Medical Laboratory MLA Electra 1000 C 4929 Protein C 4 HIGH July 26, 1993
18359 K944227 40208 Medical Laboratory MLA Electra 1400C 4929 Protein C 4 HIGH April 7, 1995
18360 K931206 40167 Medical Laboratory MLA Electra 1600C 4929 Protein C 4 HIGH November 22, 1993
18361 K962664 40282 Medical Laboratory MLA Electra 1800C 4929 Protein C 4 HIGH December 5, 1997
18362 40041 Medical Laboratory MLA Electra 900 4929 Protein C 4 HIGH July 26, 1993
18363 40042 Medical Laboratory MLA Electra 900C 4929 Protein C 4 HIGH July 26, 1993
18364 K924453 46144 Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 4929 Protein C 4 HIGH November 22, 1993
18365 46123 Ortho Koagulab 32-S 4929 Protein C 4 HIGH July 26, 1993
18366 46128 Ortho Koagulab CTS 4929 Protein C 4 HIGH July 26, 1993
18367 55068 Ramco Laboratories Spectro C 4929 Protein C 4 HIGH July 26, 1993
18368 K972342 55288 Reaads Medical Products Protein C Antigen Test Kit 4929 Protein C 4 HIGH March 6, 1998
18369 K922201 55044 Roche Diagnostics Cobas Mira 4929 Protein C 4 HIGH November 22, 1993
18370 K922201 55367 Roche Diagnostics Hitachi 704 4929 Protein C 4 HIGH May 7, 1999
18371 K922201 55401 Roche Diagnostics Hitachi 717 4929 Protein C 4 HIGH May 7, 1999
18372 58050 Sigma Diagnostics AccuStasis 2000 4929 Protein C 4 HIGH July 26, 1993
18373 K992321 58606 Sysmex CA-6000 4929 Protein C 4 HIGH January 27, 2000
18374 K992321 61283 TOA Medical Electronics CA-6000 4929 Protein C 4 HIGH January 18, 2000
18375 K950015 61180 The Binding Site Human Protein C RID 4929 Protein C 4 HIGH March 10, 1995
18376 K931992 67075 Vitek HEMOLAB 4929 Protein C 4 HIGH January 6, 1995
18377 K934210 67086 Vitek HEMOLAB Protein C chrom (manual) 4929 Protein C 4 HIGH January 6, 1995
18379 7370 Beckman Paragon HRE Electrophoresis Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18380 7374 Beckman Paragon Immunoelectrophoresis (IEP) Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18381 7375 Beckman Paragon Immunofixation Electrophoresis (IFE) Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18382 7369 Beckman Paragon SPE Electrophoresis Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18383 7368 Beckman Paragon SPE-II Electrophoresis Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18385 K963018 7934 Bio-Rad BioFocus Capillary Electrophoresis (with reanalysis) 4920 Protein Fractions 2 HIGH September 26, 1997
18386 K964453 25274 Helena Laboratories REP 3 Flur SPE-60 4920 Protein Fractions 2 HIGH June 13, 1997
18387 25066 Helena Laboratories REP SPE Plus 4920 Protein Fractions 2 HIGH July 26, 1993
18388 25069 Helena Laboratories REP SPE Plus (Ponceau S) 4920 Protein Fractions 2 HIGH July 26, 1993
18389 25064 Helena Laboratories REP SPE Template (Ponceau S) Procedure 4920 Protein Fractions 2 HIGH July 26, 1993
18390 25067 Helena Laboratories REP SPE Template Procedure 4920 Protein Fractions 2 HIGH July 26, 1993
18391 K973316 25286 Helena Laboratories REP SPE Vis 4920 Protein Fractions 2 HIGH March 6, 1998
18392 K972274 25287 Helena Laboratories SPIFE SPE Vis-60 4920 Protein Fractions 2 HIGH March 6, 1998
18393 25006 Helena Laboratories Super Z Serum Protein Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18394 25007 Helena Laboratories Titan Gel High Resolution Protein Kit 4920 Protein Fractions 2 HIGH July 26, 1993
18395 25063 Helena Laboratories Titan Gel Multi-Slot SP Electrophoresis System 4920 Protein Fractions 2 HIGH July 26, 1993
18396 25062 Helena Laboratories Titan Gel Serum Protein System 4920 Protein Fractions 2 HIGH July 26, 1993
18397 K960029 58393 Sebia HYDRASYS {Hydragel 15/30 Protein (E)} 4920 Protein Fractions 2 HIGH July 26, 1996
18398 K982450 58595 Sebia HYDRASYS {Hydragel 5 Proteinurie} 4920 Protein Fractions 2 HIGH January 26, 2000
18399 K982450 58598 Sebia HYDRASYS {Hydragel 7/15 HR} 4920 Protein Fractions 2 HIGH January 26, 2000
18400 E980001 58512 Sebia HYDRASYS {Hydragel 7/15/30 B1-B2} 4920 Protein Fractions 2 HIGH June 5, 1998
18401 K960669 58399 Sebia HYDRASYS {Hydragel IF//IF Penta} 4920 Protein Fractions 2 HIGH July 19, 1996
18402 K982450 58601 Sebia Hydragel -Mini HR/HR Urine Kit (manual) 4920 Protein Fractions 2 HIGH January 26, 2000
18403 K960669 58398 Sebia Hydragel IF/Double IF/IF Penta (manual) 4920 Protein Fractions 2 HIGH July 19, 1996
18404 K951536 58367 Sebia Hydragel Protein Kit (manual) 4920 Protein Fractions 2 HIGH July 7, 1995
18405 K982450 58599 Sebia Hydragel Proteinurie Kit (manual) 4920 Protein Fractions 2 HIGH January 26, 2000
18406 K924767 61389 The Binding Site Serum Protein Electropheresis (SPE) Kit 4920 Protein Fractions 2 HIGH February 12, 1999
18407 K924767 61392 The Binding Site Urine Protein Electropheresis (UPE) Kit 4920 Protein Fractions 2 HIGH March 12, 1999
18408 K904297 4728 American Bioproducts ST4 BIO 4930 Protein S 4 HIGH June 20, 1997
18409 K961579 4677 American Bioproducts STA Compact Analyzer 4930 Protein S 4 HIGH November 1, 1996
18410 K983460 4875 American Bioproducts STA-R Analyzer 4930 Protein S 4 HIGH October 25, 1999
18411 4360 American Diagnostica Rellplate S 4930 Protein S 4 HIGH July 26, 1993
18412 7220 Biopool Protein S EID Kit 4930 Protein S 4 HIGH July 26, 1993
18413 K954017 13404 Diagnostica Stago ASSERACHROM Free Protein S 4930 Protein S 4 HIGH November 24, 1995
18414 13131 Diagnostica Stago ASSERACHROM Protein S 4930 Protein S 4 HIGH July 26, 1993
18415 K954040 13403 Diagnostica Stago ASSERACHROM Total Protein S 4930 Protein S 4 HIGH November 24, 1995
18416 13139 Diagnostica Stago Assera-Plate Protein S 4930 Protein S 4 HIGH July 26, 1993
18417 13150 Diagnostica Stago LIATEST Protein S 4930 Protein S 4 HIGH July 26, 1993
18418 13218 Diagnostica Stago ST4 4930 Protein S 4 HIGH July 26, 1993
18419 25048 Helena Laboratories Protein S Antigen Rocket EID 4930 Protein S 4 HIGH July 26, 1993
18420 K930327 28075 Instrumentation Laboratory IL ACL 200 4930 Protein S 4 HIGH November 22, 1993
18421 K930327 28076 Instrumentation Laboratory IL ACL 2000 4930 Protein S 4 HIGH November 22, 1993
18422 K930327 28077 Instrumentation Laboratory IL ACL 300 4930 Protein S 4 HIGH November 22, 1993
18423 K930327 28197 Instrumentation Laboratory IL ACL 300 Plus 4930 Protein S 4 HIGH November 22, 1993
18424 K930327 28078 Instrumentation Laboratory IL ACL 3000 4930 Protein S 4 HIGH November 22, 1993
18425 K930327 28079 Instrumentation Laboratory IL ACL 3000 Plus 4930 Protein S 4 HIGH November 22, 1993
18426 K961991 28454 Instrumentation Laboratory IL ACL 6000 4930 Protein S 4 HIGH September 13, 1996
18427 K961991 28487 Instrumentation Laboratory IL ACL 7000 4930 Protein S 4 HIGH September 19, 1997
18428 K930327 28080 Instrumentation Laboratory IL ACL 810 4930 Protein S 4 HIGH November 22, 1993
18429 37033 LAbor COA Screener 4930 Protein S 4 HIGH July 26, 1993
18430 K983914 55639 Reaads Medical Products Monoclonal Free Protein S Antigen Test Kit 4930 Protein S 4 HIGH October 25, 1999
18431 K972482 55286 Reaads Medical Products Protein S Antigen Test Kit 4930 Protein S 4 HIGH March 6, 1998
18432 K951640 61228 The Binding Site Human Protein S 'NL' NANORID RID 4930 Protein S 4 HIGH April 25, 1997
18441 K930823 13286 Diagnostic Specialties Protein-Bound Glucose Assay Kit 4963 Protein, Glycated 2 HIGH November 22, 1993
18453 4035 Abbott Bichromatic ABA 100 4921 Protein, Total 2 HIGH July 26, 1993
18454 4036 Abbott Bichromatic ABA 200 4921 Protein, Total 2 HIGH July 26, 1993
18455 4267 Abbott Bichromatic ABA 50 4921 Protein, Total 2 HIGH July 26, 1993
18466 4275 Ames OPTIMATE 4921 Protein, Total 2 HIGH July 26, 1993
18490 7278 Bio-Rad Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18521 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 4921 Protein, Total 2 HIGH July 26, 1993
18533 16010 Electronucleonics FLEXIGEM 4921 Protein, Total 2 HIGH July 26, 1993
18539 K864743 25214 Horizon Total Protein (manual) 4921 Protein, Total 2 HIGH April 28, 1995
18540 28157 Instrumentation Laboratory IL 504 4921 Protein, Total 2 HIGH July 26, 1993
18548 28183 Instrumentation Laboratory Multistat III 4921 Protein, Total 2 HIGH July 26, 1993
18549 28184 Instrumentation Laboratory Multistat III Plus 4921 Protein, Total 2 HIGH July 26, 1993
18569 34050 Kenlor Industries Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18581 40126 Mallinckrodt Serometer 370 4921 Protein, Total 2 HIGH July 26, 1993
18582 40123 Medical Analysis Systems Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18583 40118 Meditech Diagnostic System Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18610 49064 Pointe Scientific 180 Chemistry Analyzer 4921 Protein, Total 2 HIGH July 26, 1993
18612 55075 Reagents Applications RAICHEM Test Kit (manual) 4921 Protein, Total 2 HIGH July 26, 1993
18633 K941496 58347 STC Technologies Total Protein Micro-Plate Assay 4921 Protein, Total 2 HIGH December 9, 1994
18638 58185 Seragen StatEase 4921 Protein, Total 2 HIGH July 26, 1993
18639 58165 Sherwood Medical Rapid Stat Diagnostic Kit 4921 Protein, Total 2 HIGH July 26, 1993
18640 58051 Sigma Diagnostics Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18641 58195 SmithKline ESKALAB-CCS 4921 Protein, Total 2 HIGH July 26, 1993
18642 58210 Stanbio Premiere 4921 Protein, Total 2 HIGH July 26, 1993
18643 58229 Sterling Diagnostics Analyzer 2000 4921 Protein, Total 2 HIGH July 26, 1993
18645 K882938 61377 TECO Diagnostics TC 84 4921 Protein, Total 2 HIGH November 19, 1998
18646 K864743 61420 TECO Diagnostics Total Protein Reagent Set (manual) 4921 Protein, Total 2 HIGH March 26, 1999
18647 61044 TRACE Scientific Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18658 61014 Technicon SMA 12/60 4921 Protein, Total 2 HIGH July 26, 1993
18659 61016 Technicon SMAC 4921 Protein, Total 2 HIGH July 26, 1993
18660 61045 Technicon SMAC 2 4921 Protein, Total 2 HIGH July 26, 1993
18661 61046 Technicon SMAC 3 4921 Protein, Total 2 HIGH July 26, 1993
18662 70102 Wako Autokit 4921 Protein, Total 2 HIGH July 26, 1993
18665 70110 Wako Micro TP Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
18696 K951222 55106 Randox Laboratories Test Kit 4972 Protein, Total (urine) 2 HIGH April 26, 1996
18702 4526 Advanced Clinical Tech. Periocheck Enzyme Activity Kit 4965 Proteolytic enzymes 2 HIGH September 1, 1994
18703 46103 Organon Teknika Thrombonostika 4933 Prothrombin Fragment 1.2 (F1.2) 4 HIGH July 26, 1993
18705 4424 All Manual Tilt-Tube Coagulation Procedures 4922 Prothrombin Time (PT) 4 HIGH July 26, 1993
18741 K951820 25244 Helena Laboratories Thromboplastin Reagent-LI (manual) 4922 Prothrombin Time (PT) 4 HIGH January 26, 1996
18742 K940310 25163 Helena Laboratories Thromboplastin Reagent-MI (manual) 4922 Prothrombin Time (PT) 4 HIGH September 15, 1994
18803 K935748 46149 Ortho RecombiPlasTin II (manual) 4922 Prothrombin Time (PT) 4 HIGH May 5, 1995
18804 K940082 49154 Pacific Hemostasis ThromboScreen Thromboplastin-DS (manual) 4922 Prothrombin Time (PT) 4 HIGH April 14, 1995
18846 28183 Instrumentation Laboratory Multistat III 4941 Pyruvate 2 HIGH July 26, 1993
18849 58051 Sigma Diagnostics Test Kit 4944 Pyruvate kinase 2 HIGH July 26, 1993
18853 4275 Ames OPTIMATE 5202 Quinidine 7 HIGH July 26, 1993
18854 4156 Ames TDA 5202 Quinidine 7 HIGH July 26, 1993
18860 7383 Beckman Auto ICS 5202 Quinidine 7 HIGH July 26, 1993
18861 7381 Beckman ICS 5202 Quinidine 7 HIGH July 26, 1993
18862 7382 Beckman ICS II 5202 Quinidine 7 HIGH July 26, 1993
18889 28183 Instrumentation Laboratory Multistat III 5202 Quinidine 7 HIGH July 26, 1993
18890 28184 Instrumentation Laboratory Multistat III Plus 5202 Quinidine 7 HIGH July 26, 1993
18910 58082 Syva Emit Test Kit 5202 Quinidine 7 HIGH July 26, 1993
18933 22010 Gamma Arachis hypogea Lectin 5501 RBC antigen type other than A or B 5 HIGH July 26, 1993
18935 22019 Gamma Lectin System 5501 RBC antigen type other than A or B 5 HIGH July 26, 1993
18971 4301 All Manual Red Blood Cell Count Procedures 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
18997 10103 Coulter A 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19002 10185 Coulter B 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19005 10180 Coulter Counter Model A 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19006 10186 Coulter D 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19007 10104 Coulter D2 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19008 10108 Coulter F 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19009 10109 Coulter FN 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19043 K952308 10325 Coulter Z1 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH November 3, 1995
19044 K991070 10479 Coulter Z2 Analyzer 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 9, 1999
19045 10126 Coulter ZBI 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19046 10127 Coulter ZBI6 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19047 10128 Coulter ZF 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19048 10129 Coulter ZF5 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19049 10130 Coulter ZM 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH July 26, 1993
19050 13277 DMA H3-HCT 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19051 13280 DMA H5 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19052 13279 DMA H5-M 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19053 13281 DMA H7 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19083 40171 Mallinckrodt H5-M 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19084 40170 Mallinckrodt S-630 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19085 40172 Mallinckrodt S-650 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19086 40173 Mallinckrodt S-670 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19126 58305 SmithKline ESKALAB-CHS H10 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19127 58300 SmithKline ESKALAB-CHS H3-HCT 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19128 58301 SmithKline ESKALAB-CHS H3-Hgb 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19129 58303 SmithKline ESKALAB-CHS H5 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19130 58302 SmithKline ESKALAB-CHS H5-M 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19131 58304 SmithKline ESKALAB-CHS H7 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19175 61127 Texas International Laboratories H10 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19177 61121 Texas International Laboratories H3-HCT 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19178 61122 Texas International Laboratories H3-Hgb 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19179 61124 Texas International Laboratories H5 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19180 61123 Texas International Laboratories H5-M 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19181 61125 Texas International Laboratories H7 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
19193 10060 Clinical Assays GammaCoat 5515 Renin 6 HIGH July 26, 1993
19194 K925998 43062 Nichols Institute BV Active Renin RIA 5515 Renin 6 HIGH November 22, 1993
19197 K932787 7534 Behring Batroxobin (manual) 5521 Reptilase Time 4 HIGH September 30, 1994
19198 K955115 7737 Biopool Venom Time Reagent (manual) 5521 Reptilase Time 4 HIGH April 12, 1996
19206 K854081 4216 Analytab API IMAGEN RSV (direct Ag) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19207 7034 Baxter Bartels RSV (FA) Test Kit (direct Ag) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19208 7358 Baxter Bartels RSV (FA) Test Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19209 7035 Baxter Bartels Viral Respiratory Kit (direct Ag) 5503 Respiratory syncytial virus 10 HIGH September 1, 1994
19210 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH September 1, 1994
19211 K854081 13335 DAKO IMAGEN RSV (direct Ag) 5503 Respiratory syncytial virus 10 HIGH March 3, 1995
19212 K943317 13324 Diagnostic Products Corp. PathoDx RSV Kit (direct Ag) 5503 Respiratory syncytial virus 10 HIGH January 6, 1995
19213 K943317 13325 Diagnostic Products Corp. PathoDx RSV Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH January 6, 1995
19214 K912842 22108 Gull Laboratories RSV-MAb Test (including cell culture) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19215 K852185 28597 INTRACEL Bartels RSV (FA) Test Kit (direct Ag) 5503 Respiratory syncytial virus 10 HIGH January 18, 2000
19216 K852185 28598 INTRACEL Bartels RSV (FA) Test Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH January 18, 2000
19217 28599 INTRACEL Bartels Viral Respiratory Kit (direct Ag) 5503 Respiratory syncytial virus 10 HIGH January 18, 2000
19218 28600 INTRACEL Bartels Viral Respiratory Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH January 18, 2000
19219 K922801 37068 Light Diagnostics Respir. Panel 1 Screen & ID Kit (including cell culture) 5503 Respiratory syncytial virus 10 HIGH November 22, 1993
19220 K942173 43094 NeoGenex RSV Antigen Test (including cell culture) 5503 Respiratory syncytial virus 10 HIGH September 15, 1994
19221 46080 Ortho RSV (IFA) (direct Ag) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19222 46098 Ortho RSV Antigen ELISA Test (direct Ag/spectrophotometric) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19223 58006 Sanofi/Kallestad Pathfinder RSV (direct Ag/spectrophotometric) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19224 58005 Sanofi/Kallestad Pathfinder RSV (direct Ag/visual) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19225 K924289 58286 Sanofi/Kallestad RSV Microplate EIA (direct Ag/spectrophotometric) 5503 Respiratory syncytial virus 10 HIGH November 22, 1993
19226 67043 Vitek RSV Direct IF (direct Ag) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19227 67038 Vitek Systems Vidas 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
19228 7806 bioMerieux Vitek VIDAS 5503 Respiratory syncytial virus 10 HIGH October 25, 1996
19229 22091 Gull Laboratories RSV Antibodies IFA Test 5504 Respiratory syncytial virus Antibodies 3 HIGH July 26, 1993
19230 67026 Virgo RSV Antibody IFA Test 5504 Respiratory syncytial virus Antibodies 3 HIGH July 26, 1993
19231 K962037 13458 DAKO IMAGEN Respiratory Screen (direct specimen) 5505 Respiratory viruses 10 HIGH June 20, 1997
19232 K962037 13459 DAKO IMAGEN Respiratory Screen (including cell culture) 5505 Respiratory viruses 10 HIGH June 20, 1997
19239 K923790 7639 Becton Dickinson FACSCalibur 5506 Reticulocyte Count 4 HIGH April 7, 1995
19241 K872166 7497 Becton Dickinson FACScan 5506 Reticulocyte Count 4 HIGH September 1, 1994
19242 K923790 7637 Becton Dickinson FACSort 5506 Reticulocyte Count 4 HIGH April 7, 1995
19264 7117 Behring LC-partigen Kit 5507 Retinol binding protein (RBP) 2 HIGH July 26, 1993
19268 K955881 61253 The Binding Site Human Retinol Binding Protein 'NL' NANORID 5507 Retinol binding protein (RBP) 2 HIGH September 6, 1996
19269 K973189 61292 The Binding Site Human Retinol Binding Protein NANORID for Urine 5507 Retinol binding protein (RBP) 2 HIGH February 20, 1998
19270 4007 ALerCHEK RF Assay 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19279 7383 Beckman Auto ICS 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19280 7381 Beckman ICS 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19281 7382 Beckman ICS II 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19299 7328 BioWhittaker FIAX System 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19307 K924056 10242 Clark Laboratories Encore Rheumatoid Factor (RF) EIA Test 5508 Rheumatoid Factor (RF) 3 HIGH November 22, 1993
19309 K993304 10498 Cogent Diagnostics AUTOSTAT II Rheumatoid Factor IgG 5508 Rheumatoid Factor (RF) 3 HIGH January 7, 2000
19311 K974889 13533 Diamedix Immunosimplicity (Is)-RF (manual) 5508 Rheumatoid Factor (RF) 3 HIGH October 16, 1998
19318 25013 Hemagen RF 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19319 K962836 25261 Hemagen Rheumatoid Factor Kit EIA 5508 Rheumatoid Factor (RF) 3 HIGH October 4, 1996
19323 K942272 28352 IMMCO Diagnostics ImmuLisa Rheumatoid Factor ELISA 5508 Rheumatoid Factor (RF) 3 HIGH October 28, 1994
19324 K983084 28551 INOVA Diagnostics QUANTA Lite RF IgA ELISA 5508 Rheumatoid Factor (RF) 3 HIGH April 2, 1999
19325 K983083 28552 INOVA Diagnostics QUANTA Lite RF IgG ELISA 5508 Rheumatoid Factor (RF) 3 HIGH April 2, 1999
19326 K971614 28483 INOVA Diagnostics QUANTA Lite RF IgM 5508 Rheumatoid Factor (RF) 3 HIGH July 11, 1997
19335 K993843 40342 Micro Detect MDI RF Test 5508 Rheumatoid Factor (RF) 3 HIGH January 18, 2000
19343 K970373 55283 RAIChem RF SPIA 5508 Rheumatoid Factor (RF) 3 HIGH February 6, 1998
19359 K942908 58333 Sigma Diagnostics Rheumatoid Factor IgM Kit 5508 Rheumatoid Factor (RF) 3 HIGH February 3, 1995
19360 58216 Sigma Diagnostics SIA Rheumatoid Factor 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
19366 K933712 61134 TheraTest Laboratories EL-RF-IgM Kit 5508 Rheumatoid Factor (RF) 3 HIGH June 10, 1994
19367 K941398 61157 TheraTest Laboratories EL-RF/3 (IgM-IgG-IgA) Kit 5508 Rheumatoid Factor (RF) 3 HIGH August 4, 1995
19368 K962050 61269 TheraTest Laboratories EL-RFscr 5508 Rheumatoid Factor (RF) 3 HIGH February 14, 1997
19376 25045 Hillcrest Biologicals Rickettsia IFA (IgG) Test 5512 Rickettsia rickettsii Ab (Rocky Mt. Spotted Fever) 3 HIGH July 26, 1993
19377 25046 Hillcrest Biologicals Rickettsia IFA (IgM) Test 5512 Rickettsia rickettsii Ab (Rocky Mt. Spotted Fever) 3 HIGH July 26, 1993
19380 25045 Hillcrest Biologicals Rickettsia IFA (IgG) Test 5514 Rickettsia typhi Ab (Typhus Antibodies) 3 HIGH July 26, 1993
19381 25046 Hillcrest Biologicals Rickettsia IFA (IgM) Test 5514 Rickettsia typhi Ab (Typhus Antibodies) 3 HIGH July 26, 1993
19384 4063 Abbott Rotazyme II Diagnostic Kit (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH July 26, 1993
19385 4064 Abbott Rotazyme II Diagnostic Kit (direct Ag/visual) 5509 Rotavirus 10 HIGH July 26, 1993
19387 4259 Analytab API Rotavirus (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH July 26, 1993
19388 4202 Analytab API Rotavirus Test Kit (direct Ag/visual) 5509 Rotavirus 10 HIGH July 26, 1993
19390 10139 Cambridge Biotech Rotaclone (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH July 26, 1993
19391 10011 Cambridge Biotech Rotaclone (direct Ag/visual) 5509 Rotavirus 10 HIGH July 26, 1993
19392 K912666 13331 DAKO ELISA Rotavirus Kit (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH March 3, 1995
19393 K932384 13295 DAKO IDEIA Rotavirus (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH March 3, 1995
19394 K932384 13294 DAKO IDEIA Rotavirus (direct Ag/visual) 5509 Rotavirus 10 HIGH March 3, 1995
19395 K951208 16131 Eldan-Tech ROTA-dan Rapid Rotavirus EIA (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH January 27, 2000
19396 K951208 16132 Eldan-Tech ROTA-dan Rapid Rotavirus EIA (direct Ag/visual) 5509 Rotavirus 10 HIGH January 27, 2000
19398 28109 Isolab RotaVirus EIA (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH July 26, 1993
19399 28086 Isolab RotaVirus EIA (direct Ag/visual) 5509 Rotavirus 10 HIGH July 26, 1993
19405 58007 Sanofi/Kallestad Pathfinder Rotavirus (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH July 26, 1993
19406 58008 Sanofi/Kallestad Pathfinder Rotavirus (direct Ag/visual) 5509 Rotavirus 10 HIGH July 26, 1993
19407 K964424 61301 Trinity Biotech Rotavirus Ag Detection ELISA (direct Ag/spectrophotometric) 5509 Rotavirus 10 HIGH December 5, 1997
19417 4065 Abbott Rubazyme 5510 Rubella Antibodies 3 HIGH July 26, 1993
19418 4337 Analytab ACCU-LYZA Rubella IgG ELISA Test System 5510 Rubella Antibodies 3 HIGH July 26, 1993
19419 4339 Analytab ACCU-LYZA Rubella IgM ELISA Test System 5510 Rubella Antibodies 3 HIGH July 26, 1993
19420 7295 Baxter Bartels PRIMA Rubella IgG EIA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19421 7294 Baxter Bartels PRIMA Rubella IgM EIA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19422 K922586 7513 Baxter Bartels Rubella Virus IgG PRIMA System EIA 5510 Rubella Antibodies 3 HIGH November 22, 1993
19423 K922581 7512 Baxter Bartels Rubella Virus IgM PRIMA System EIA 5510 Rubella Antibodies 3 HIGH November 22, 1993
19431 7328 BioWhittaker FIAX System 5510 Rubella Antibodies 3 HIGH July 26, 1993
19432 7341 BioWhittaker RUBECAP-M 5510 Rubella Antibodies 3 HIGH July 26, 1993
19433 7342 BioWhittaker RUBELISA II 5510 Rubella Antibodies 3 HIGH July 26, 1993
19434 7343 BioWhittaker RUBESTAT 5510 Rubella Antibodies 3 HIGH July 26, 1993
19435 7344 BioWhittaker RUBESTAT M 5510 Rubella Antibodies 3 HIGH July 26, 1993
19438 K883924 10305 Centocor CAPTIA Rubella-G 5510 Rubella Antibodies 3 HIGH May 12, 1995
19439 K885300 10304 Centocor CAPTIA Rubella-M 5510 Rubella Antibodies 3 HIGH May 12, 1995
19443 K883924 13343 DAKO IDEIA Rubella-G 5510 Rubella Antibodies 3 HIGH March 3, 1995
19444 K885300 13344 DAKO IDEIA Rubella-M 5510 Rubella Antibodies 3 HIGH March 3, 1995
19447 K981729 13511 Diamedix Immunosimplicity (Is)-Rubella IgG (manual/qualitative) 5510 Rubella Antibodies 3 HIGH February 5, 1999
19448 K981729 13512 Diamedix Immunosimplicity (Is)-Rubella IgG (manual/quantitative) 5510 Rubella Antibodies 3 HIGH February 5, 1999
19450 13227 Diamedix Rubella IgG Microassay 5510 Rubella Antibodies 3 HIGH July 26, 1993
19456 K901635 22092 Gull Laboratories Rubella IgG ELISA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19457 K904084 22093 Gull Laboratories Rubella IgM ELISA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19458 K971304 28522 INOVA Diagnostics QUANTA Lite Rubella IgG ELISA (Arbitrary Unit (SRU) Assay) 5510 Rubella Antibodies 3 HIGH March 27, 1998
19459 K971304 28523 INOVA Diagnostics QUANTA Lite Rubella IgG ELISA (Quantitative Assay) 5510 Rubella Antibodies 3 HIGH March 27, 1998
19460 28217 Incstar Clin-ELISA Rubella IgG 5510 Rubella Antibodies 3 HIGH July 26, 1993
19466 49025 Pharmacia Rubella IgG ELISA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19468 K961053 52040 Quest International SeraQuest Rubella IgG (manual/qualitative) 5510 Rubella Antibodies 3 HIGH December 6, 1996
19469 K961053 52041 Quest International SeraQuest Rubella IgG (manual/semi-quantitative) 5510 Rubella Antibodies 3 HIGH December 6, 1996
19471 K961053 52038 Quest International SeraQuest Rubella IgG {Hyperion HyPrep Plus} (manual calculations) 5510 Rubella Antibodies 3 HIGH December 6, 1996
19472 K982281 52103 Quest International SeraQuest Rubella IgM (manual/qualitative) 5510 Rubella Antibodies 3 HIGH December 8, 1998
19473 K982281 52104 Quest International SeraQuest Rubella IgM (manual/semi-quantitative) 5510 Rubella Antibodies 3 HIGH December 8, 1998
19475 K982281 52106 Quest International SeraQuest Rubella IgM {Hyperion HyPrep Plus} (manual calculations) 5510 Rubella Antibodies 3 HIGH December 8, 1998
19479 58136 Sanofi Pasteur Platelia Rubella IgG 5510 Rubella Antibodies 3 HIGH July 26, 1993
19487 58101 Sigma Diagnostics SIA Rubella IgG 5510 Rubella Antibodies 3 HIGH July 26, 1993
19488 58102 Sigma Diagnostics SIA Rubella IgM 5510 Rubella Antibodies 3 HIGH July 26, 1993
19489 58149 Syva MicroTrak Rubella-G EIA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19490 58150 Syva MicroTrak Rubella-M EIA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19494 67027 Virgo Rubella Antibody IFA Test 5510 Rubella Antibodies 3 HIGH July 26, 1993
19499 79023 Zeus Scientific Rubella IgG ELISA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19500 79036 Zeus Scientific Rubella IgM ELISA 5510 Rubella Antibodies 3 HIGH July 26, 1993
19502 7291 Baxter Bartels PRIMA Rubeola IgG EIA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19503 7290 Baxter Bartels PRIMA Rubeola IgM EIA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19504 K922330 7511 Baxter Bartels Rubeola Virus IgG PRIMA System EIA 5511 Rubeola Antibodies (measles) 3 HIGH November 22, 1993
19505 K922335 7510 Baxter Bartels Rubeola Virus IgM PRIMA System EIA 5511 Rubeola Antibodies (measles) 3 HIGH November 22, 1993
19506 7313 Bio-Medical Virotech ELISA Antibody Test 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19507 7328 BioWhittaker FIAX System 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19508 7334 BioWhittaker MEASELESTAT 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19509 7335 BioWhittaker MEASELESTAT M 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19510 7336 BioWhittaker MEASELISA II 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19511 7158 Bion Measles-G Antibody Test System 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19512 7159 Bion Measles-M Antibody Test System 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19513 K974552 13532 Diamedix Immunosimplicity (Is)-Measles IgG (manual) 5511 Rubeola Antibodies (measles) 3 HIGH October 16, 1998
19515 13246 Diamedix Measels IgG Microassay 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19516 22094 Gull Laboratories Rubeola IFA Antibodies Test 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19517 K904854 22095 Gull Laboratories Rubeola IgG ELISA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19518 K904083 22096 Gull Laboratories Rubeola IgM ELISA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19519 K971620 28485 INOVA Diagnostics QUANTA Lite Rubeola (Measles) IgG ELISA 5511 Rubeola Antibodies (measles) 3 HIGH August 8, 1997
19520 28218 Incstar Clin-ELISA Rubeola IgG 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19521 49026 Pharmacia Measles IgG ELISA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19522 49027 Pharmacia Measles IgM ELISA 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19523 K973906 52069 Quest International SeraQuest Measles IgG (manual/qualitative) 5511 Rubeola Antibodies (measles) 3 HIGH January 16, 1998
19524 K973906 52070 Quest International SeraQuest Measles IgG (manual/semi-quantitative) 5511 Rubeola Antibodies (measles) 3 HIGH January 16, 1998
19526 K973906 52072 Quest International SeraQuest Measles IgG {Hyperion HyPrep Plus} (manual calculations) 5511 Rubeola Antibodies (measles) 3 HIGH January 16, 1998
19528 58176 Sigma Diagnostics SIA Measles IgG 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19529 58177 Sigma Diagnostics SIA Measles IgM 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19531 67024 Virgo Measles Antibody IFA Test 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19533 79021 Zeus Scientific Measles 5511 Rubeola Antibodies (measles) 3 HIGH July 26, 1993
19537 4036 Abbott Bichromatic ABA 200 5801 Salicylates 7 HIGH July 26, 1993
19543 7383 Beckman Auto ICS 5801 Salicylates 7 HIGH July 26, 1993
19544 7381 Beckman ICS 5801 Salicylates 7 HIGH July 26, 1993
19545 7382 Beckman ICS II 5801 Salicylates 7 HIGH July 26, 1993
19576 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 5801 Salicylates 7 HIGH July 26, 1993
19590 22140 GDS Diagnostics Enzymatic Test Kit 5801 Salicylates 7 HIGH July 26, 1993
19595 28183 Instrumentation Laboratory Multistat III 5801 Salicylates 7 HIGH July 26, 1993
19596 28184 Instrumentation Laboratory Multistat III Plus 5801 Salicylates 7 HIGH July 26, 1993
19647 58165 Sherwood Medical Rapid Stat Diagnostic Kit 5801 Salicylates 7 HIGH July 26, 1993
19648 58051 Sigma Diagnostics Test Kit 5801 Salicylates 7 HIGH July 26, 1993
19649 58157 Stanbio Test Kit 5801 Salicylates 7 HIGH July 26, 1993
19653 4203 Analytab API SerImm Sure Salmonella (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19654 7200 Becton Dickinson BBL Salmonella Grouping (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19655 7132 Bio-Medical ANI Salmonella Test (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19656 13212 Difco Bacto Salmonella H (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19657 13118 Difco Bacto Salmonella O (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19658 13153 Difco FA Salmonella Panvalent (including broth culture) 5802 Salmonella 8 HIGH July 26, 1993
19659 13154 Difco FA Salmonella Poly (including broth culture) 5802 Salmonella 8 HIGH July 26, 1993
19660 55090 Roach Laboratories Salmonella Flagellar (H) (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19661 55091 Roach Laboratories Salmonella Somatic & Vi (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19662 K951069 58363 SA Scientific SAS Salmonella H Antisera (including culture) 5802 Salmonella 8 HIGH June 16, 1995
19663 K912791 58255 SMI MED. Salmonella O Grouping (including culture) 5802 Salmonella 8 HIGH November 22, 1993
19665 70081 Wampole Bactigen Salmonella-Shigella (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19666 70034 Wellcome Wellcolex Colour Salmonella (including culture) 5802 Salmonella 8 HIGH July 26, 1993
19667 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 5835 Sarcosine 2 HIGH November 10, 1994
19669 4162 Amico Amizyme Schistosoma species Ab Test System 5803 Schistosoma Antibodies 3 HIGH July 26, 1993
19673 25115 Hamilton-Thorn HTM-IVOS (morphology) 5822 Semen 4 HIGH July 26, 1993
19676 K821186 58352 Serono Penetrak 5822 Semen 4 HIGH January 20, 1995
19677 58275 Sperm Penetration Assay 5822 Semen 4 HIGH July 26, 1993
19678 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 5834 Serine 2 HIGH November 10, 1994
19679 28153 Immunotech Urinary Serotonin Enzyme Immunoassay 5820 Serotonin 6 HIGH July 26, 1993
19680 E990021 34113 KMI Diagnostics Serotonin ELISA 5820 Serotonin 6 HIGH May 7, 1999
19683 13205 Diagnostic Systems Sex Hormone Binding Globulin RIA Kit 5819 Sex Hormone Binding Globulin 6 HIGH July 26, 1993
19684 67011 Ventrex Coated Tube RIA 5819 Sex Hormone Binding Globulin 6 HIGH July 26, 1993
19685 K940449 70154 Wallac Oy DELFIA SHBG Kit 5819 Sex Hormone Binding Globulin 6 HIGH September 1, 1994
19686 13174 Difco Bacto Shigella (including culture) 5804 Shigella 8 HIGH July 26, 1993
19687 55086 Roach Laboratories Shigella Grouping & Typing (including culture) 5804 Shigella 8 HIGH July 26, 1993
19688 K953316 58387 SA Scientific SAS Shigella Antisera (including culture) 5804 Shigella 8 HIGH October 20, 1995
19689 70081 Wampole Bactigen Salmonella-Shigella (including culture) 5804 Shigella 8 HIGH July 26, 1993
19690 70035 Wellcome Wellcolex Colour Shigella (including culture) 5804 Shigella 8 HIGH July 26, 1993
19691 4275 Ames OPTIMATE 5824 Sisomicin 7 HIGH July 26, 1993
19712 4035 Abbott Bichromatic ABA 100 5805 Sodium 2 HIGH July 26, 1993
19713 4267 Abbott Bichromatic ABA 50 5805 Sodium 2 HIGH July 26, 1993
19740 7062 Beckman Flame Photometer 5805 Sodium 2 HIGH July 26, 1993
19766 7423 Boehringer Mannheim LyteTek Flame Photometer 5805 Sodium 2 HIGH July 26, 1993
19829 28158 Instrumentation Laboratory IL 508 5805 Sodium 2 HIGH July 26, 1993
19832 28081 Instrumentation Laboratory IL Flame Photometer/Elect 5805 Sodium 2 HIGH July 26, 1993
19974 55577 Roche Diagnostics LyteTek Flame Photometer 5805 Sodium 2 HIGH May 7, 1999
19978 58157 Stanbio Test Kit 5805 Sodium 2 HIGH July 26, 1993
19979 58230 Sterling Diagnostics Test Kit 5805 Sodium 2 HIGH July 26, 1993
19981 K902572 61419 TECO Diagnostics Sodium Reagent Set (manual) 5805 Sodium 2 HIGH March 26, 1999
19982 K882938 61377 TECO Diagnostics TC 84 5805 Sodium 2 HIGH November 19, 1998
19991 61015 Technicon SMA 6/60 5805 Sodium 2 HIGH July 26, 1993
19992 61016 Technicon SMAC 5805 Sodium 2 HIGH July 26, 1993
19993 61045 Technicon SMAC 2 5805 Sodium 2 HIGH July 26, 1993
19994 61046 Technicon SMAC 3 5805 Sodium 2 HIGH July 26, 1993
19997 4035 Abbott Bichromatic ABA 100 5823 Sorbital Dehydrogenase (SDH) 2 HIGH July 26, 1993
19998 4036 Abbott Bichromatic ABA 200 5823 Sorbital Dehydrogenase (SDH) 2 HIGH July 26, 1993
20009 28183 Instrumentation Laboratory Multistat III 5823 Sorbital Dehydrogenase (SDH) 2 HIGH July 26, 1993
20029 4091 Adams Scientific SeroStat II Staphylococcus (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20030 4098 Advanced Medical Technologies Rapi-Staph (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20031 4698 Arlington Scientific Staphslide (including culture) 5807 Staphylococcus 8 HIGH April 18, 1997
20032 7047 Baxter MicroScan StaphyLatex (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20033 7082 Becton Dickinson BBL Staphyloslide (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20034 7133 Bio-Medical ANI Staph aureus Test (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20035 10023 Carr-Scarborough Accu-Staph (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20037 13056 Difco Bacto Staph Latex Test (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20038 22040 Gen-Probe AccuProbe (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20041 28034 Immuno-Mycologics LA-Staph (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20042 28055 Innovative Diagnostic Systems IDS Staphylochrome (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20043 E980010 40320 Murex Staphaurex Gold 5807 Staphylococcus 8 HIGH January 11, 1999
20044 K945538 40200 Murex Staphaurex Plus (including culture) 5807 Staphylococcus 8 HIGH June 9, 1995
20045 43001 NCS StaphSlide (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20046 K972030 46322 Oxoid DrySpot Staphytect Plus (including culture) 5807 Staphylococcus 8 HIGH November 1, 1999
20047 55015 Regional Media Lab Hemastaph (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20048 K852997 55215 Remel Staph Latex Kit (including culture) 5807 Staphylococcus 8 HIGH December 6, 1996
20050 E990007 61391 The Binding Site Staphylococcus Latex Kit 5807 Staphylococcus 8 HIGH March 12, 1999
20051 K926173 61129 Trinity Laboratories STAPH-A-LEX System (including culture) 5807 Staphylococcus 8 HIGH November 22, 1993
20052 64019 Unipath Oxoid Staphylase Test (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20053 K940557 64030 Unipath Staphytect-OD (including culture) 5807 Staphylococcus 8 HIGH November 10, 1994
20054 67031 Vitek Systems RAPIDEC Staph (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20055 67077 Vitek Systems Slidex Staph-Kit (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20056 70026 Wellcome Staphaurex (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
20057 40106 Meridian Diagnostics Endo-Staph 5818 Staphylococcus aureus Antibodies 3 HIGH July 26, 1993
20059 K935519 4561 AB Biodisk Etest for S. pneumoniae (including culture) 5808 Streptococcus pneumoniae 8 HIGH December 9, 1994
20060 7081 Becton Dickinson BBL Pneumoslide (including culture) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20061 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 5808 Streptococcus pneumoniae 8 HIGH June 7, 1996
20062 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20066 13161 Difco FA Pneumococcus Poly (direct Ag) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20067 22040 Gen-Probe AccuProbe (including culture) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20069 34007 Karobio Phadebact Pneumococcus (including culture) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20071 70080 Wampole Bactigen Meningitis Panel (blood culture supernatant) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
20074 K961423 4736 Abbott Signify Strep A (including culture) 5810 Streptococcus, group A 8 HIGH September 12, 1997
20077 K952819 4626 Abbott TestPack +Plus Strep A with OBC (including culture) 5810 Streptococcus, group A 8 HIGH February 2, 1996
20079 4483 Abbott TestPack Plus Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20081 K971522 4811 Abbott TestPack Plus Strep A with OBC II (including culture) 5810 Streptococcus, group A 8 HIGH January 11, 1999
20083 4077 Abbott TestPack Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20086 4092 Adams Scientific SeroStat Streptococcus (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20089 4222 Antibodies Inc. Detect-A-Strep (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20095 7257 Becton Dickinson Culturette GrpA Strep (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20096 K951542 7662 Becton Dickinson Directigen 1-2-3 Group A Strep (including culture) 5810 Streptococcus, group A 8 HIGH October 27, 1995
20103 K923673 7427 Becton Dickinson Precise STREP A (including culture) 5810 Streptococcus, group A 8 HIGH November 22, 1993
20111 K961423 7925 BioStar Acceava Strep A Test (including culture) 5810 Streptococcus, group A 8 HIGH July 18, 1997
20120 13025 Diagnostic Products PathoDx LA Strep Group (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20121 13119 Difco Bacto Strep Grouping Kit (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20122 13157 Difco FA Streptococcus Groups (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20126 22040 Gen-Probe AccuProbe (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20127 K924715 22165 Gen-Probe Group A Streptococcus Direct (direct from throat swab) 5810 Streptococcus, group A 8 HIGH June 10, 1994
20132 28043 Incstar Group A Streptococcus Fluoro-Kit (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20134 K881457 31065 Johnson & Johnson CDI SureCell (including culture) 5810 Streptococcus, group A 8 HIGH October 6, 1995
20135 34008 Karobio Phadebact Streptococcus (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20138 34039 Kodak SureCell (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20140 37016 Leeco Diagnostics Preview Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20141 K962296 37152 LifeSign Streptolex STAT (including culture) 5810 Streptococcus, group A 8 HIGH October 8, 1999
20145 40046 Medical Technology Corp. OPTITEC Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20152 40055 Medix Biotech Sure-Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20155 40069 Meridian Diagnostics Meritec-Strep (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20156 40108 Meridian Diagnostics Meritec-Strep Group A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20159 43042 NCS StrepSlide (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20166 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5810 Streptococcus, group A 8 HIGH February 3, 1995
20172 K942093 55139 Remel RIM Strep Grouping LA Test (including culture) 5810 Streptococcus, group A 8 HIGH December 9, 1994
20178 K924007 58293 Syntron Bioresearch QuikPac Strep A EIA (including culture) 5810 Streptococcus, group A 8 HIGH November 22, 1993
20180 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5810 Streptococcus, group A 8 HIGH March 12, 1999
20182 K982373 61394 Trinity Biotech Uni-Gold Strep A (including culture) 5810 Streptococcus, group A 8 HIGH March 12, 1999
20185 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20188 67009 V-Tech V-Trend Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20190 67052 Vitek Systems Slidex Strepto A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20191 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20195 70023 Wellcome Reveal Colour Strep A (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20196 70027 Wellcome Streptex (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
20198 K961423 70196 Wyntek Diagnostics OSOM Strep A Test (including culture) 5810 Streptococcus, group A 8 HIGH March 21, 1997
20199 4092 Adams Scientific SeroStat Streptococcus (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20201 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 5811 Streptococcus, group B 8 HIGH June 7, 1996
20202 7260 Becton Dickinson Directigen Meningitis Combo Kit (blood culture supernatant) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20204 7261 Becton Dickinson Directigen Meningitis Indiv.Kit (blood culture supernatant) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20208 13025 Diagnostic Products PathoDx LA Strep Group (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20209 13119 Difco Bacto Strep Grouping Kit (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20210 13157 Difco FA Streptococcus Groups (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20211 22040 Gen-Probe AccuProbe (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20212 25051 Hybritech Icon Strep B (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20214 34008 Karobio Phadebact Streptococcus (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20215 K962296 37152 LifeSign Streptolex STAT (including culture) 5811 Streptococcus, group B 8 HIGH October 8, 1999
20216 40069 Meridian Diagnostics Meritec-Strep (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20217 40107 Meridian Diagnostics Meritec-Strep Group B (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20218 43042 NCS StrepSlide (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20220 K931713 49115 Pacific Biotech Cards O.S. Strep B (including culture) 5811 Streptococcus, group B 8 HIGH June 10, 1994
20221 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5811 Streptococcus, group B 8 HIGH February 3, 1995
20223 K942093 55139 Remel RIM Strep Grouping LA Test (including culture) 5811 Streptococcus, group B 8 HIGH December 9, 1994
20224 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5811 Streptococcus, group B 8 HIGH March 12, 1999
20225 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20226 67051 Vitek Systems Slidex Strepto B (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20227 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20228 70078 Wampole Bactigen Group B Strep (blood culture supernatant) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20232 70027 Wellcome Streptex (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20233 70082 Wellcome Wellcogen Bacterial Ag Kit (blood culture supernatant) 5811 Streptococcus, group B 8 HIGH July 26, 1993
20235 4092 Adams Scientific SeroStat Streptococcus (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20236 7083 Becton Dickinson BBL Strep Grouping (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20237 13025 Diagnostic Products PathoDx LA Strep Group (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20238 13119 Difco Bacto Strep Grouping Kit (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20239 13157 Difco FA Streptococcus Groups (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20240 34008 Karobio Phadebact Streptococcus (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20241 K962296 37152 LifeSign Streptolex STAT (including culture) 5812 Streptococcus, group C 8 HIGH October 8, 1999
20242 40069 Meridian Diagnostics Meritec-Strep (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20243 43042 NCS StrepSlide (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20244 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5812 Streptococcus, group C 8 HIGH February 3, 1995
20245 K942093 55139 Remel RIM Strep Grouping LA Test (including culture) 5812 Streptococcus, group C 8 HIGH December 9, 1994
20246 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5812 Streptococcus, group C 8 HIGH March 12, 1999
20247 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20248 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20249 70027 Wellcome Streptex (including culture) 5812 Streptococcus, group C 8 HIGH July 26, 1993
20250 7134 Bio-Medical ANI Strep Test (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20251 13040 Diagnostic Products Corp. PathoDx Strep D (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20252 13119 Difco Bacto Strep Grouping Kit (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20253 13157 Difco FA Streptococcus Groups (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20254 34008 Karobio Phadebact Streptococcus (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20255 43042 NCS StrepSlide (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20256 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5813 Streptococcus, group D 8 HIGH March 12, 1999
20257 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20258 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20259 70027 Wellcome Streptex (including culture) 5813 Streptococcus, group D 8 HIGH July 26, 1993
20260 4092 Adams Scientific SeroStat Streptococcus (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20261 7083 Becton Dickinson BBL Strep Grouping (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20262 13025 Diagnostic Products PathoDx LA Strep Group (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20263 13119 Difco Bacto Strep Grouping Kit (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20264 13157 Difco FA Streptococcus Groups (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20265 34008 Karobio Phadebact Streptococcus (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20266 K962296 37152 LifeSign Streptolex STAT (including culture) 5814 Streptococcus, group F 8 HIGH October 8, 1999
20267 40069 Meridian Diagnostics Meritec-Strep (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20268 43042 NCS StrepSlide (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20269 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5814 Streptococcus, group F 8 HIGH February 3, 1995
20270 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20271 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20272 70027 Wellcome Streptex (including culture) 5814 Streptococcus, group F 8 HIGH July 26, 1993
20273 4092 Adams Scientific SeroStat Streptococcus (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20274 7083 Becton Dickinson BBL Strep Grouping (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20275 13025 Diagnostic Products PathoDx LA Strep Group (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20276 13119 Difco Bacto Strep Grouping Kit (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20277 13157 Difco FA Streptococcus Groups (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20278 34008 Karobio Phadebact Streptococcus (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20279 K962296 37152 LifeSign Streptolex STAT (including culture) 5815 Streptococcus, group G 8 HIGH October 8, 1999
20280 40069 Meridian Diagnostics Meritec-Strep (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20281 43042 NCS StrepSlide (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20282 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5815 Streptococcus, group G 8 HIGH February 3, 1995
20283 K942093 55139 Remel RIM Strep Grouping LA Test (including culture) 5815 Streptococcus, group G 8 HIGH December 9, 1994
20284 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5815 Streptococcus, group G 8 HIGH March 12, 1999
20285 64012 Unipath Oxoid Streptococcal Grouping Kit (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20286 67053 Vitek Systems Slidex Strepto-Kit (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20287 70027 Wellcome Streptex (including culture) 5815 Streptococcus, group G 8 HIGH July 26, 1993
20291 4072 Abbott TDX FLx 5833 Surfactant/Albumin Ratio 2 HIGH September 1, 1994
20292 K980088 4837 Alfa Scientific Designs T-Uptake Microplate EIA 6156 T Uptake (TU) 6 HIGH July 23, 1999
20331 34022 Kronus Kalibre-R TSH Receptor (TRAb) Kit 6101 TSH Receptor Antibody 3 HIGH July 26, 1993
20332 P970007 4056 Abbott IMX 6164 Tacrolimus 7 HIGH January 11, 1999
20333 37022 LMD Laboratories Cysticercosis Microtiter ELISA (spectrophotometric) 6128 Taenia solium Antibodies (Cysticercosis) 3 HIGH July 26, 1993
20334 37049 LMD Laboratories Cysticercosis Microtiter ELISA (visual) 6128 Taenia solium Antibodies (Cysticercosis) 3 HIGH July 26, 1993
20335 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6141 Taurine 2 HIGH November 10, 1994
20336 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 6141 Taurine 2 HIGH May 26, 1995
20340 7138 Bio-Rad CoTube 6102 Testosterone 6 HIGH July 26, 1993
20341 K955102 7829 BioChem Immunosystems Biodata Testosterone MAIA 6102 Testosterone 6 HIGH January 17, 1997
20351 10060 Clinical Assays GammaCoat 6102 Testosterone 6 HIGH July 26, 1993
20352 13030 Diagnostic Products Corp. Coat-A-Count 6102 Testosterone 6 HIGH July 26, 1993
20353 13031 Diagnostic Products Corp. Double Antibody 6102 Testosterone 6 HIGH July 26, 1993
20354 13203 Diagnostic Systems Active Testosterone RIA Kit 6102 Testosterone 6 HIGH July 26, 1993
20355 K971823 13462 Diagnostic Systems DSL-10-4000 ACTIVE Testosterone EIA 6102 Testosterone 6 HIGH July 25, 1997
20356 13194 Diagnostic Systems Testosterone RIA Kit 6102 Testosterone 6 HIGH July 26, 1993
20357 37029 Leeco Diagnostics RIA Test Kit 6102 Testosterone 6 HIGH July 26, 1993
20361 58091 Serono Baker Serozyme 6102 Testosterone 6 HIGH July 26, 1993
20363 58251 Serono Diagnostics Serozyme 6102 Testosterone 6 HIGH July 26, 1993
20365 K932951 70155 Wallac Oy DELFIA Testosterone Kit 6102 Testosterone 6 HIGH November 22, 1993
20366 13030 Diagnostic Products Corp. Coat-A-Count 6122 Testosterone, Free 6 HIGH July 26, 1993
20367 K952281 13393 Diagnostic Systems Active Free Testosterone RIA 6122 Testosterone, Free 6 HIGH July 28, 1995
20375 4275 Ames OPTIMATE 6104 Theophylline 7 HIGH July 26, 1993
20387 7383 Beckman Auto ICS 6104 Theophylline 7 HIGH July 26, 1993
20388 7381 Beckman ICS 6104 Theophylline 7 HIGH July 26, 1993
20389 7382 Beckman ICS II 6104 Theophylline 7 HIGH July 26, 1993
20423 10061 Clinical Assays GammaDab 6104 Theophylline 7 HIGH July 26, 1993
20437 13030 Diagnostic Products Corp. Coat-A-Count 6104 Theophylline 7 HIGH July 26, 1993
20450 22140 GDS Diagnostics Enzymatic Test Kit 6104 Theophylline 7 HIGH July 26, 1993
20452 28173 Immunotech EZ-BEAD EIA Kit 6104 Theophylline 7 HIGH July 26, 1993
20459 28184 Instrumentation Laboratory Multistat III Plus 6104 Theophylline 7 HIGH July 26, 1993
20498 49064 Pointe Scientific 180 Chemistry Analyzer 6104 Theophylline 7 HIGH July 26, 1993
20507 K961462 55236 Roche Diagnostics Cobas Mira {CEDIA} (manual curve) 6104 Theophylline 7 HIGH May 16, 1997
20521 58210 Stanbio Premiere 6104 Theophylline 7 HIGH July 26, 1993
20522 58082 Syva Emit Test Kit 6104 Theophylline 7 HIGH July 26, 1993
20532 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6142 Threonine 2 HIGH November 10, 1994
20536 K930157 7495 Behring Test Thrombin (manual) 6105 Thrombin Time 4 HIGH November 22, 1993
20574 28183 Instrumentation Laboratory Multistat III 6105 Thrombin Time 4 HIGH July 26, 1993
20575 28184 Instrumentation Laboratory Multistat III Plus 6105 Thrombin Time 4 HIGH July 26, 1993
20611 K925493 67090 Vitek HEMOLAB Thrombicalci-Test (manual) 6105 Thrombin Time 4 HIGH September 15, 1994
20612 K922934 7483 Behring Enzygnost TAT 6136 Thrombin/antithrombin III Complex (TAT) 4 HIGH November 22, 1993
20613 K962176 4774 American Biogenetic Sciences TpP EIA 6162 Thrombus precursor Protein (TpP) 4 HIGH January 23, 1998
20614 K950217 4616 ALPCO ORGenTec PIA Thyroglobulin EIA 6124 Thyroglobulin 2 HIGH May 5, 1995
20615 K972190 4773 ALPCO ORGenTec Thyroglobulin ELISA 6124 Thyroglobulin 2 HIGH January 23, 1998
20616 13031 Diagnostic Products Corp. Double Antibody 6124 Thyroglobulin 2 HIGH July 26, 1993
20617 K991720 34116 Kronus OptiQuant Thyroglobulin Kit 6124 Thyroglobulin 2 HIGH November 1, 1999
20620 4061 Abbott RIA Bead 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20621 K771222 4866 Alfa Scientific Designs Thyrotropin (TSH) Coated Tube IRMA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH August 12, 1999
20622 K971780 4868 Alfa Scientific Designs Thyrotropin (TSH) ELISA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH August 12, 1999
20624 4148 Amersham Amerlite 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20627 7247 Becton Dickinson MAb Solid Phase Component System 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20628 7106 Becton Dickinson SimulTRAC 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20629 7109 Becton Dickinson Solid Phase 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20633 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20634 7138 Bio-Rad CoTube 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20635 7139 Bio-Rad Echoclonal 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20638 K991146 8248 BioCheck Thyroid Stimulating Hormone (TSH) EIA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH December 22, 1999
20647 10050 Ciba Corning MAB (monoclonal) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20648 10051 Ciba Corning Magic (MGC) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20649 10055 Ciba Corning Magic Lite 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20651 10061 Clinical Assays GammaDab 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20658 13030 Diagnostic Products Corp. Coat-A-Count 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20659 13109 Diagnostic Products Corp. Coat-A-Count IRMA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20660 13031 Diagnostic Products Corp. Double Antibody 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20661 13111 Diagnostic Products Corp. Milenia 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20662 13229 Diamedix TSH Microassay 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20668 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20669 25053 Hybritech Photon Immunoassay Analyzer 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20670 25022 Hybritech Tandem-E 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20671 25023 Hybritech Tandem-R 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20672 28173 Immunotech EZ-BEAD EIA Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20673 28175 Immunotech Microzyme EIA (spectrophotometric) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20674 37028 Leeco Diagnostics IRMA Test Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20675 37029 Leeco Diagnostics RIA Test Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20677 40117 Medix Biotech EIA Test Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20678 K971780 40289 Monobind Thyrotropin (TSH) ELISA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH February 20, 1998
20679 43065 Nichols Institute Chemiluminescence TSH Assay 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH September 1, 1994
20681 46007 Organon NML IRMA Test Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20682 46008 Organon NML L.E.S. 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20688 49064 Pointe Scientific 180 Chemistry Analyzer 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20690 K930776 55129 Roche Diagnostics Cobas Core TSH EIA (manual) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH June 10, 1994
20694 58009 Sanofi/Kallestad Quanticlone 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20695 K942661 58350 SeaLite Sciences AquaLite TSH (manual curve) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH January 20, 1995
20697 58091 Serono Baker Serozyme 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20699 58251 Serono Diagnostics Serozyme 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20700 58048 Serono Maiaclone 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20701 58108 Sigma Diagnostics SIA Thyroid Stimulating Hormone 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20703 K961629 61426 TECO Diagnostics TSH EIA Set (Bead Assay) 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH March 26, 1999
20708 67011 Ventrex Coated Tube RIA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20710 70142 Wallac Oy DELFIA hTSH Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH September 1, 1994
20711 70129 Wallac Oy DELFIA hTSH Ultra Kit 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
20713 7223 Becton Dickinson Neonatal TSH Immunoradiometric Assay 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH July 26, 1993
20715 K935049 7555 Bioclone ELEGANCE Neonatal TSH ELISA (computer calculations) 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH November 10, 1994
20716 K935049 7554 Bioclone ELEGANCE Neonatal TSH ELISA (manual calculations) 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH November 10, 1994
20717 7256 Biomerica RIA Test Kit 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH July 26, 1993
20718 K943195 13109 Diagnostic Products Corp. Coat-A-Count IRMA 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH March 17, 1995
20719 13031 Diagnostic Products Corp. Double Antibody 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH July 26, 1993
20720 40085 Micromedic Systems CONCEPT 4 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH July 26, 1993
20721 40111 Micromedic Systems Concept 4 Plus 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH July 26, 1993
20722 K942658 49126 Pantex NEOSCREEN ELISA TSH 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH March 3, 1995
20724 70156 Wallac Oy DELFIA Neo-hTSH Kit 6107 Thyroid Stimulating Hormone (TSH) (Neonatal) 6 HIGH September 1, 1994
20742 K990993 8251 BioCheck Sensitive Thyroid Stimulating Hormone (S-TSH) EIA 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH December 22, 1999
20746 10060 Clinical Assays GammaCoat 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20750 25052 Hybritech Photon ERA Automated Immunoassay Analyzer 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20751 25053 Hybritech Photon Immunoassay Analyzer 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20752 25022 Hybritech Tandem-E 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20753 25023 Hybritech Tandem-R 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20754 K952211 31016 Johnson & Johnson CDL Amerlite Analyzer 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH August 18, 1995
20755 40085 Micromedic Systems CONCEPT 4 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20756 40111 Micromedic Systems Concept 4 Plus 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20757 43008 Nichols Institute Allegro RIA 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20761 58009 Sanofi/Kallestad Quanticlone 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
20768 4519 Abbott Tetrabead-125 6109 Thyroxine (T4) 6 HIGH September 1, 1994
20771 K921935 4858 Alfa Scientific Designs Thyroxine (T4) Coated Tube RIA 6109 Thyroxine (T4) 6 HIGH July 23, 1999
20772 K971709 4843 Alfa Scientific Designs Total Thyroxine (T4) Direct ELISA 6109 Thyroxine (T4) 6 HIGH July 23, 1999
20774 4148 Amersham Amerlite 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20793 K925842 7106 Becton Dickinson SimulTRAC 6109 Thyroxine (T4) 6 HIGH November 22, 1993
20797 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20800 7271 Bio-Rad Quanta-Count 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20801 7142 Bio-Rad Quantimune II 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20804 K991432 8249 BioCheck Total Thyroxine (T4) EIA 6109 Thyroxine (T4) 6 HIGH December 22, 1999
20806 7275 Biomerica EIA Test Kit 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20825 10051 Ciba Corning Magic (MGC) 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20826 10055 Ciba Corning Magic Lite 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20828 10060 Clinical Assays GammaCoat 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20840 13030 Diagnostic Products Corp. Coat-A-Count 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20841 13111 Diagnostic Products Corp. Milenia 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20842 K971269 13463 Diagnostic Systems DSL-10-3200 ACTIVE Thyroxine (T4) EIA 6109 Thyroxine (T4) 6 HIGH July 25, 1997
20843 K954312 13406 Diagnostic Systems DSL-3200 ACTIVE Thyroxine RIA 6109 Thyroxine (T4) 6 HIGH October 13, 1995
20852 28172 Immunotech ENDAB EIA Kit 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20853 28173 Immunotech EZ-BEAD EIA Kit 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20854 28175 Immunotech Microzyme EIA (spectrophotometric) 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20858 28183 Instrumentation Laboratory Multistat III 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20859 28184 Instrumentation Laboratory Multistat III Plus 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20861 34031 Kallestad Quanticoat 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20863 40117 Medix Biotech EIA Test Kit 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20864 40085 Micromedic Systems CONCEPT 4 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20865 K971709 40286 Monobind Total Thyroxine (T4) Microplate EIA 6109 Thyroxine (T4) 6 HIGH February 20, 1998
20866 43070 Nichols Institute Chemiluminescence Total T4 Assay 6109 Thyroxine (T4) 6 HIGH September 1, 1994
20881 46012 Organon NML Tetra Tab 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20882 46013 Organon NML Tetra Tube 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20888 49064 Pointe Scientific 180 Chemistry Analyzer 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20890 K932605 55131 Roche Diagnostics Cobas Core T4 EIA (manual) 6109 Thyroxine (T4) 6 HIGH June 10, 1994
20914 58010 Sanofi/Kallestad Quanticoat 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20917 58091 Serono Baker Serozyme 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20918 58251 Serono Diagnostics Serozyme 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20919 58210 Stanbio Premiere 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20920 58082 Syva Emit Test Kit 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20922 K920766 61428 TECO Diagnostics T4 EIA Set (Bead Assay) 6109 Thyroxine (T4) 6 HIGH March 26, 1999
20937 K962211 64034 United Biotech UBI MAGIWEL T4 (Thyroxine) Quantitative 6109 Thyroxine (T4) 6 HIGH November 8, 1996
20938 67011 Ventrex Coated Tube RIA 6109 Thyroxine (T4) 6 HIGH July 26, 1993
20942 70145 Wallac Oy DELFIA T4 Kit 6109 Thyroxine (T4) 6 HIGH September 1, 1994
20945 13030 Diagnostic Products Corp. Coat-A-Count 6123 Thyroxine (T4), Neonatal 6 HIGH July 26, 1993
20946 40085 Micromedic Systems CONCEPT 4 6123 Thyroxine (T4), Neonatal 6 HIGH July 26, 1993
20947 40111 Micromedic Systems Concept 4 Plus 6123 Thyroxine (T4), Neonatal 6 HIGH July 26, 1993
20948 K972974 43127 Neometrics Accuwell T4 EIA 6123 Thyroxine (T4), Neonatal 6 HIGH October 9, 1998
20949 58010 Sanofi/Kallestad Quanticoat 6123 Thyroxine (T4), Neonatal 6 HIGH July 26, 1993
20950 K943416 70168 Wallac Oy DELFIA Neonatal Thyroxine (T4) Kit 6123 Thyroxine (T4), Neonatal 6 HIGH March 17, 1995
20956 10061 Clinical Assays GammaDab 6110 Thyroxine Binding Globulin (TBG) 6 HIGH July 26, 1993
20957 K952284 31016 Johnson & Johnson CDL Amerlite Analyzer 6110 Thyroxine Binding Globulin (TBG) 6 HIGH August 18, 1995
20961 70146 Wallac Oy DELFIA TBG Kit 6110 Thyroxine Binding Globulin (TBG) 6 HIGH September 1, 1994
20971 4147 Amersham Amerlex-M 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20972 4148 Amersham Amerlite 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20979 7247 Becton Dickinson MAb Solid Phase Component System 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20980 7106 Becton Dickinson SimulTRAC 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20981 7110 Becton Dickinson Solid Phase Coated Tube 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20985 7138 Bio-Rad CoTube 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20986 7141 Bio-Rad Quantimune 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
20989 K982954 8148 Biomerica Free T4 Microwell EIA 6111 Thyroxine, Free (FT4) 6 HIGH January 22, 1999
20999 10051 Ciba Corning Magic (MGC) 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21000 10055 Ciba Corning Magic Lite 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21003 10059 Clinical Assays Direct FT4 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21004 10064 Clinical Assays Two Step 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21010 13030 Diagnostic Products Corp. Coat-A-Count 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21012 K934012 28326 Immunotech Free T4 RIA Kit 6111 Thyroxine, Free (FT4) 6 HIGH May 20, 1994
21013 28175 Immunotech Microzyme EIA (spectrophotometric) 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21014 28166 International Immunoassay Labs SPIRIA-FT4 RIA Kit 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21017 43071 Nichols Institute Chemiluminescence Free T4 Assay 6111 Thyroxine, Free (FT4) 6 HIGH September 1, 1994
21018 43056 Nichols Institute Free T4 by Equilibrium Dialysis 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21024 K932607 55128 Roche Diagnostics Cobas Core FT4 EIA (manual) 6111 Thyroxine, Free (FT4) 6 HIGH June 10, 1994
21029 K925649 58289 STC Technologies Free T-4 Micro-Plate EIA 6111 Thyroxine, Free (FT4) 6 HIGH November 22, 1993
21031 K974551 58489 SeaLite Sciences AquaLite Free T4 (computer calculations) 6111 Thyroxine, Free (FT4) 6 HIGH January 16, 1998
21032 K974551 58490 SeaLite Sciences AquaLite Free T4 (manual curve) 6111 Thyroxine, Free (FT4) 6 HIGH January 16, 1998
21033 58091 Serono Baker Serozyme 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21035 58251 Serono Diagnostics Serozyme 6111 Thyroxine, Free (FT4) 6 HIGH July 26, 1993
21045 70143 Wallac Oy DELFIA Free T4 Kit 6111 Thyroxine, Free (FT4) 6 HIGH September 1, 1994
21047 K951965 13499 DAKO Envision System, HRP 6163 Tissue (Cell) Antigens 3 HIGH July 17, 1998
21048 K951965 13500 DAKO LSAB 2 Kit, HRP 6163 Tissue (Cell) Antigens 3 HIGH July 17, 1998
21049 K940424 67099 Ventana Blue Alkaline Phosphatase Blue Detection Kit 6163 Tissue (Cell) Antigens 3 HIGH July 17, 1998
21050 67082 Ventana Red, Alkaline Phosphatase Fast Red Detection Kit (tissue specimen) 6163 Tissue (Cell) Antigens 3 HIGH September 1, 1994
21051 4361 American Diagnostica Spectrolyse/Fibrin 6130 Tissue Plasminogen Activator (t-PA) 4 HIGH July 26, 1993
21052 K962489 7928 Biopool Chromolize tPA Assay Kit 6130 Tissue Plasminogen Activator (t-PA) 4 HIGH August 8, 1997
21053 K934314 7525 Biopool TintElize tPA 6130 Tissue Plasminogen Activator (t-PA) 4 HIGH June 10, 1994
21054 K971519 13475 Diagnostica Stago ASSERACHROM tPA 6130 Tissue Plasminogen Activator (t-PA) 4 HIGH January 9, 1998
21055 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 6130 Tissue Plasminogen Activator (t-PA) 4 HIGH July 26, 1993
21059 4275 Ames OPTIMATE 6112 Tobramycin 7 HIGH July 26, 1993
21060 4156 Ames TDA 6112 Tobramycin 7 HIGH July 26, 1993
21067 7383 Beckman Auto ICS 6112 Tobramycin 7 HIGH July 26, 1993
21068 7381 Beckman ICS 6112 Tobramycin 7 HIGH July 26, 1993
21069 7382 Beckman ICS II 6112 Tobramycin 7 HIGH July 26, 1993
21090 10060 Clinical Assays GammaCoat 6112 Tobramycin 7 HIGH July 26, 1993
21116 28183 Instrumentation Laboratory Multistat III 6112 Tobramycin 7 HIGH July 26, 1993
21117 28184 Instrumentation Laboratory Multistat III Plus 6112 Tobramycin 7 HIGH July 26, 1993
21200 4079 Abbott Toxo-G EIA Kit 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21201 4080 Abbott Toxo-M EIA Kit 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21202 4163 Amico Amizyme Toxoplasma gondii Ab Test System 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21203 4336 Analytab ACCU-LYZA Toxo IgG ELISA Test System 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21204 4342 Analytab ACCU-LYZA Toxo IgM ELISA Test System 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21205 7292 Baxter Bartels PRIMA Toxoplasma IgG EIA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21206 7293 Baxter Bartels PRIMA Toxoplasma IgM EIA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21207 K922585 7515 Baxter Bartels Toxo IgG PRIMA System EIA 6113 Toxoplasma gondii Antibodies 3 HIGH November 22, 1993
21208 K922579 7514 Baxter Bartels Toxo IgM PRIMA System EIA 6113 Toxoplasma gondii Antibodies 3 HIGH November 22, 1993
21217 7328 BioWhittaker FIAX System 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21218 7347 BioWhittaker TOXOCAP-M 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21219 7348 BioWhittaker TOXOELISA II 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21220 7349 BioWhittaker TOXOSTAT 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21221 7350 BioWhittaker TOXOSTAT M 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21222 K944867 7564 BioWhittaker TOXOSTAT Test 6113 Toxoplasma gondii Antibodies 3 HIGH May 17, 1996
21225 K880918 10308 Centocor CAPTIA Toxo-G 6113 Toxoplasma gondii Antibodies 3 HIGH May 12, 1995
21226 K900655 10307 Centocor CAPTIA Toxo-M 6113 Toxoplasma gondii Antibodies 3 HIGH May 12, 1995
21230 K900655 13341 DAKO IDEIA Toxo-M 6113 Toxoplasma gondii Antibodies 3 HIGH March 3, 1995
21233 K981498 13508 Diamedix Immunosimplicity (Is)-Toxoplasma IgG (manual/qualitative) 6113 Toxoplasma gondii Antibodies 3 HIGH August 28, 1998
21234 K981498 13509 Diamedix Immunosimplicity (Is)-Toxoplasma IgG (manual/quantitative) 6113 Toxoplasma gondii Antibodies 3 HIGH August 28, 1998
21236 13232 Diamedix Toxoplasma IgG Microassay 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21237 13233 Diamedix Toxoplasma IgM Microassay 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21243 22217 GenBio Toxoplasmosis IgG IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH August 1, 1997
21244 22216 GenBio Toxoplasmosis IgM IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH August 1, 1997
21248 22149 General Biometrics Toxoplasmosis IgG IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21249 22148 General Biometrics Toxoplasmosis IgM IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21250 K772243 22097 Gull Laboratories Toxo IFA Antibodies Test 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21251 K900354 22098 Gull Laboratories Toxo IgG ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21252 K962343 22188 Gull Laboratories Toxo IgG ELISA (qualitative) 6113 Toxoplasma gondii Antibodies 3 HIGH April 25, 1997
21253 K962343 22187 Gull Laboratories Toxo IgG ELISA (quantitative) 6113 Toxoplasma gondii Antibodies 3 HIGH April 25, 1997
21254 K903324 22099 Gull Laboratories Toxo IgM ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21255 K880007 22100 Gull Laboratories Toxo IgM IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21257 K971441 28508 INOVA Diagnostics QUANTA Lite Toxoplasma IgG ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH December 19, 1997
21258 28215 Incstar Clin-ELISA Toxoplasma gondii IgG 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21259 28042 Incstar Fluoro-Kit 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21260 K963296 28469 Incstar Toxoplasma IgG ELISA Kit 6113 Toxoplasma gondii Antibodies 3 HIGH January 24, 1997
21261 37021 LMD Laboratories Toxoplasma IgG Microtiter ELISA (spectrophotometric) 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21262 37051 LMD Laboratories Toxoplasma IgG Microtiter ELISA (visual) 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21265 46035 Organon Teknika Toxo IFA Kit I 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21269 49028 Pharmacia Toxoplasma gondii IgG ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21270 K960092 52042 Quest International SeraQuest Toxo IgG (manual/qualitative) 6113 Toxoplasma gondii Antibodies 3 HIGH December 6, 1996
21272 K960092 52044 Quest International SeraQuest Toxo IgG {Hyperion HyPrep Plus} (manual calculations) 6113 Toxoplasma gondii Antibodies 3 HIGH December 6, 1996
21273 K971672 52057 Quest International SeraQuest Toxo IgM (manual/qualitative) 6113 Toxoplasma gondii Antibodies 3 HIGH October 31, 1997
21274 K971672 52058 Quest International SeraQuest Toxo IgM (manual/semi-quantitative) 6113 Toxoplasma gondii Antibodies 3 HIGH October 31, 1997
21276 K971672 52059 Quest International SeraQuest Toxo IgM {Hyperion HyPrep Plus} (manual calculations) 6113 Toxoplasma gondii Antibodies 3 HIGH October 31, 1997
21280 58138 Sanofi Pasteur Platelia Toxo IgG 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21281 58139 Sanofi Pasteur Platelia Toxo IgM 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21288 58179 Sigma Diagnostics SIA Toxoplasma IgG 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21289 58198 Sigma Diagnostics SIA Toxoplasma IgM 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21290 58146 Syva MicroTrak Toxo-G EIA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21291 58145 Syva MicroTrak Toxo-M EIA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21293 67028 Virgo Toxoplasma gondii Antibody IFA Test 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21296 79011 Zeus Scientific IFA Toxoplasma 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21297 79026 Zeus Scientific TOXO IgG ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21298 79027 Zeus Scientific TOXO IgM ELISA 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
21299 K924882 79041 Zeus Scientific Toxo IgM IFA 6113 Toxoplasma gondii Antibodies 3 HIGH November 22, 1993
21309 7383 Beckman Auto ICS 6114 Transferrin 2 HIGH July 26, 1993
21310 7382 Beckman ICS II 6114 Transferrin 2 HIGH July 26, 1993
21328 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6114 Transferrin 2 HIGH July 26, 1993
21329 7328 BioWhittaker FIAX System 6114 Transferrin 2 HIGH July 26, 1993
21342 25005 Helena Laboratories Quiplate System for RID 6114 Transferrin 2 HIGH July 26, 1993
21343 25024 Hycor Accuplate 6114 Transferrin 2 HIGH July 26, 1993
21349 28183 Instrumentation Laboratory Multistat III 6114 Transferrin 2 HIGH July 26, 1993
21350 28184 Instrumentation Laboratory Multistat III Plus 6114 Transferrin 2 HIGH July 26, 1993
21351 34001 Kallestad Endoplate RID 6114 Transferrin 2 HIGH July 26, 1993
21352 34003 Kallestad Quantiplate RID 6114 Transferrin 2 HIGH July 26, 1993
21353 34010 Kent Radial Immunodiffusion Test 6114 Transferrin 2 HIGH July 26, 1993
21359 55074 Reagents Applications RAICHEM SPIA Test Kit (manual) 6114 Transferrin 2 HIGH July 26, 1993
21391 K932713 61044 TRACE Scientific Test Kit 6114 Transferrin 2 HIGH May 25, 1994
21397 61069 The Binding Site Human Transferrin RID 6114 Transferrin 2 HIGH July 26, 1993
21403 K970718 55246 R & D Systems Quantikine IVD human sTfR ELISA 6158 Transferrin Receptor (TfR) 2 HIGH July 25, 1997
21404 K981208 55585 Ramco Laboratories Human Transferrin Receptor (TfR) 6158 Transferrin Receptor (TfR) 2 HIGH April 2, 1999
21405 K992502 4887 Axis %CDT Turbidometric Immunoassay 6165 Transferrin, carbohydrate-deficient 2 HIGH January 18, 2000
21407 4366 ADI Visuwell Reagin (spectrophotometric) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21408 4003 ADI Visuwell Reagin (visual) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21409 K932453 4546 ADI Visuwell Syphilis Antibody 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 14, 1995
21410 4153 Ames Sera-tek 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21413 K992124 4878 Avanti Polar Lipids VDRL Antigen Slide Test 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH November 19, 1999
21414 K952802 7688 BIOMIRA Diagnostics Visuwell Reagin II 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH May 31, 1996
21416 7250 Becton Dickinson BBL Reagents for Syphilis Serology (FTA-ABS) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21417 7249 Becton Dickinson BBL Syphilis Serology Reagents (VDRL) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21423 K904524 10309 Centocor CAPTIA Syphilis-M 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH May 12, 1995
21426 13166 Diagnostic Chemicals Syphilis-G Test Kit (manual) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21427 13171 Diagnostic Chemicals Syphilis-M Test Kit (manual) 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21428 13163 Difco Bacto FTA-ABS 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21430 13057 Difco Bacto VDRL 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21431 19007 Fisher Diagnostic VDRL 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21432 K971502 19033 Fujirebio Serodia-TP.PA 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH March 6, 1998
21434 22116 Gamma Biologicals VDRL 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21435 28042 Incstar Fluoro-Kit 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21436 37113 Lee Laboratories VDRL 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH October 17, 1997
21437 40009 MarDx FTA-ABS Test System 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21440 46003 Olympus PK7100 Automated Pretransfusion Blood Test System 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21445 55073 Roach Laboratories FTA-ABS 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21446 58022 Scimedx FTA-ABS Test System 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21452 67021 Virgo FTA-ABS IFA Test 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21453 79034 Zeus Scientific FTA-ABS Double Stain 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
21455 37023 LMD Laboratories Trichinella Microtiter ELISA (spectrophotometric) 6126 Trichinella Antibodies 3 HIGH July 26, 1993
21456 37050 LMD Laboratories Trichinella Microtiter ELISA (visual) 6126 Trichinella Antibodies 3 HIGH July 26, 1993
21466 58092 Scimedx Trichomonas Test System 6116 Trichomonas 11 HIGH July 26, 1993
21473 4275 Ames OPTIMATE 6117 Tricyclic Antidepressants 7 HIGH July 26, 1993
21481 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 6117 Tricyclic Antidepressants 7 HIGH August 23, 1996
21523 58188 Syva Emit st Drug Detection System 6117 Tricyclic Antidepressants 7 HIGH July 26, 1993
21527 4035 Abbott Bichromatic ABA 100 6118 Triglyceride 2 HIGH July 26, 1993
21528 4036 Abbott Bichromatic ABA 200 6118 Triglyceride 2 HIGH July 26, 1993
21529 4267 Abbott Bichromatic ABA 50 6118 Triglyceride 2 HIGH July 26, 1993
21541 4143 American Monitor KDA 6118 Triglyceride 2 HIGH July 26, 1993
21542 4144 American Monitor Parallel 6118 Triglyceride 2 HIGH July 26, 1993
21544 4275 Ames OPTIMATE 6118 Triglyceride 2 HIGH July 26, 1993
21553 7378 Beckman Manual Spectrophotometric Test Procedure 6118 Triglyceride 2 HIGH July 26, 1993
21592 13216 DMA Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21603 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 6118 Triglyceride 2 HIGH July 26, 1993
21616 16010 Electronucleonics FLEXIGEM 6118 Triglyceride 2 HIGH July 26, 1993
21622 K933722 25167 Horizon Diagnostics Triglycerides-GPO Reagent (manual) 6118 Triglyceride 2 HIGH June 21, 1996
21623 K863923 25223 Horizon Triglyceride (INT) (manual) 6118 Triglyceride 2 HIGH April 28, 1995
21630 28183 Instrumentation Laboratory Multistat III 6118 Triglyceride 2 HIGH July 26, 1993
21631 28184 Instrumentation Laboratory Multistat III Plus 6118 Triglyceride 2 HIGH July 26, 1993
21663 40126 Mallinckrodt Serometer 370 6118 Triglyceride 2 HIGH July 26, 1993
21664 K952741 40218 MeDiTech Triglycerides (Glycerol Blk) (manual) 6118 Triglyceride 2 HIGH August 25, 1995
21665 40124 Medical Analysis Systems RefLab Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21690 49064 Pointe Scientific 180 Chemistry Analyzer 6118 Triglyceride 2 HIGH July 26, 1993
21691 K923508 55106 Randox Laboratories Test Kit 6118 Triglyceride 2 HIGH November 22, 1993
21692 55075 Reagents Applications RAICHEM Test Kit (manual) 6118 Triglyceride 2 HIGH July 26, 1993
21718 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 6118 Triglyceride 2 HIGH July 26, 1993
21719 58186 Seragen Quick-Chem 6118 Triglyceride 2 HIGH July 26, 1993
21720 58185 Seragen StatEase 6118 Triglyceride 2 HIGH July 26, 1993
21721 58051 Sigma Diagnostics Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21722 58195 SmithKline ESKALAB-CCS 6118 Triglyceride 2 HIGH July 26, 1993
21723 58210 Stanbio Premiere 6118 Triglyceride 2 HIGH July 26, 1993
21724 58157 Stanbio Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21725 58229 Sterling Diagnostics Analyzer 2000 6118 Triglyceride 2 HIGH July 26, 1993
21726 58230 Sterling Diagnostics Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21728 K882938 61377 TECO Diagnostics TC 84 6118 Triglyceride 2 HIGH November 19, 1998
21729 K880628 61421 TECO Diagnostics Triglyceride Reagent Set (manual) 6118 Triglyceride 2 HIGH March 26, 1999
21730 61044 TRACE Scientific Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21741 61014 Technicon SMA 12/60 6118 Triglyceride 2 HIGH July 26, 1993
21742 61016 Technicon SMAC 6118 Triglyceride 2 HIGH July 26, 1993
21743 61045 Technicon SMAC 2 6118 Triglyceride 2 HIGH July 26, 1993
21744 61046 Technicon SMAC 3 6118 Triglyceride 2 HIGH July 26, 1993
21747 70109 Wako Triglyceride G Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
21750 4061 Abbott RIA Bead 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21753 K971779 4841 Alfa Scientific Designs Total Triiodothyronine (T3) Direct ELISA 6119 Triiodothyronine (T3) 6 HIGH July 23, 1999
21754 K926345 4845 Alfa Scientific Designs Triiodothyronine (T3) Coated Tube RIA 6119 Triiodothyronine (T3) 6 HIGH July 23, 1999
21756 4147 Amersham Amerlex-M 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21757 4148 Amersham Amerlite 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21763 7109 Becton Dickinson Solid Phase 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21767 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21769 7142 Bio-Rad Quantimune II 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21770 K991311 8250 BioCheck Triiodothyronine (T3) EIA 6119 Triiodothyronine (T3) 6 HIGH December 22, 1999
21771 7275 Biomerica EIA Test Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21772 K960412 7774 Biomerica T3 Microwell EIA 6119 Triiodothyronine (T3) 6 HIGH April 26, 1996
21773 K981824 8161 Biotecx Laboratories OptiCoat T3 6119 Triiodothyronine (T3) 6 HIGH March 26, 1999
21782 10051 Ciba Corning Magic (MGC) 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21783 10055 Ciba Corning Magic Lite 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21786 10060 Clinical Assays GammaCoat 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21790 13030 Diagnostic Products Corp. Coat-A-Count 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21791 13031 Diagnostic Products Corp. Double Antibody 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21792 K971270 13464 Diagnostic Systems DSL-10-3200 ACTIVE Triiodothyronine EIA 6119 Triiodothyronine (T3) 6 HIGH July 25, 1997
21793 28172 Immunotech ENDAB EIA Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21794 28173 Immunotech EZ-BEAD EIA Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21795 28175 Immunotech Microzyme EIA (spectrophotometric) 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21797 34031 Kallestad Quanticoat 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21798 40117 Medix Biotech EIA Test Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21799 40085 Micromedic Systems CONCEPT 4 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21800 40111 Micromedic Systems Concept 4 Plus 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21801 K926345 40164 Monobind Coated Tube RIA Test System 6119 Triiodothyronine (T3) 6 HIGH November 22, 1993
21802 K971779 40285 Monobind Total Triiodothyronine (T3) Microplate EIA 6119 Triiodothyronine (T3) 6 HIGH February 20, 1998
21803 K923015 43072 Nichols Institute Chemiluminescence Total T3 Assay 6119 Triiodothyronine (T3) 6 HIGH November 22, 1993
21805 46007 Organon NML IRMA Test Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21821 58010 Sanofi/Kallestad Quanticoat 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21822 58091 Serono Baker Serozyme 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21824 58251 Serono Diagnostics Serozyme 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21825 58210 Stanbio Premiere 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
21827 K893620 61427 TECO Diagnostics T3 EIA Set (Bead Assay) 6119 Triiodothyronine (T3) 6 HIGH March 26, 1999
21834 K961236 64035 United Biotech UBI MAGIWEL T3 (Triiodothyronine) Quantitative 6119 Triiodothyronine (T3) 6 HIGH November 8, 1996
21837 70144 Wallac Oy DELFIA T3 Kit 6119 Triiodothyronine (T3) 6 HIGH September 1, 1994
21841 4081 Abbott Triobead 125 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21843 4148 Amersham Amerlite 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21860 7109 Becton Dickinson Solid Phase 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21863 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21883 10053 Ciba Corning Magic (MGC) (35-45 normal range) 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21884 10055 Ciba Corning Magic Lite 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21887 10060 Clinical Assays GammaCoat 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21896 13030 Diagnostic Products Corp. Coat-A-Count 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21907 28173 Immunotech EZ-BEAD EIA Kit 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21908 28175 Immunotech Microzyme EIA (spectrophotometric) 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21912 34031 Kallestad Quanticoat 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21914 40085 Micromedic Systems CONCEPT 4 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21915 40111 Micromedic Systems Concept 4 Plus 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21916 K980088 40306 Monobind T-Uptake Microplate EIA 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH August 28, 1998
21917 K926220 43087 Nichols Institute Chemiluminescence T3 Uptake Assay 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH May 20, 1994
21932 46014 Organon NML Tri Tab 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21933 46015 Organon NML Tri Tube T3U 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21940 49064 Pointe Scientific 180 Chemistry Analyzer 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21959 58010 Sanofi/Kallestad Quanticoat 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21961 58091 Serono Baker Serozyme 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21963 58251 Serono Diagnostics Serozyme 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
21980 4148 Amersham Amerlite 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21984 7141 Bio-Rad Quantimune 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21993 10051 Ciba Corning Magic (MGC) 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21995 10060 Clinical Assays GammaCoat 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21996 13030 Diagnostic Products Corp. Coat-A-Count 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21998 34049 Kodak Amerlex MAB 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
21999 34048 Kodak Amerlite MAB 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
22001 43078 Nichols Institute Chemiluminescence Free T3 Assay 6121 Triiodothyronine, Free (FT3) 6 HIGH September 1, 1994
22004 K942376 55135 Roche Diagnostics Cobas Core Free T3 EIA (manual) 6121 Triiodothyronine, Free (FT3) 6 HIGH April 28, 1995
22009 58091 Serono Baker Serozyme 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
22010 58251 Serono Diagnostics Serozyme 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
22051 28183 Instrumentation Laboratory Multistat III 6129 Trypsin 2 HIGH July 26, 1993
22052 28184 Instrumentation Laboratory Multistat III Plus 6129 Trypsin 2 HIGH July 26, 1993
22053 K932406 43089 NuClin Diagnostics NuCliTryp RIA 6129 Trypsin 2 HIGH June 10, 1994
22054 58134 Sorin Biomedica Trypsik 6129 Trypsin 2 HIGH July 26, 1993
22055 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6144 Tryptophan 2 HIGH November 10, 1994
22056 K970093 4696 Astoria-Pacific API 300 SPOTCHECK System 6143 Tyrosine 2 HIGH March 27, 1998
22057 K970093 4781 Astoria-Pacific SPOTCHECK Analyzer 6143 Tyrosine 2 HIGH April 3, 1998
22058 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6143 Tyrosine 2 HIGH November 10, 1994
22059 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 6143 Tyrosine 2 HIGH May 26, 1995
22061 4131 All RBC antibody detection 1 Stage Enzyme Procedures 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22062 4132 All RBC antibody detection 2 Stage Enzyme Procedures 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22063 4185 Amtec Ficin Treated Screening Cells 1,2,3 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22067 13019 Dade Rap-I.D. Polycation Potentiator System 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22072 22017 Gamma Ficin-Duet System 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22073 22018 Gamma Ficin-Pool 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22077 28019 Immucor Capture-R Ready-Screen 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22080 28022 Immucor Panoscreen I and II, Ficin-Treated 6412 Unexpected RBC antibody - detection-serum, plasma 5 HIGH July 26, 1993
22084 K942984 4554 AMRESCO BUN Reagent (manual) 6403 Urea (BUN) 2 HIGH March 10, 1995
22090 4035 Abbott Bichromatic ABA 100 6403 Urea (BUN) 2 HIGH July 26, 1993
22091 4036 Abbott Bichromatic ABA 200 6403 Urea (BUN) 2 HIGH July 26, 1993
22092 4267 Abbott Bichromatic ABA 50 6403 Urea (BUN) 2 HIGH July 26, 1993
22104 4143 American Monitor KDA 6403 Urea (BUN) 2 HIGH July 26, 1993
22105 4144 American Monitor Parallel 6403 Urea (BUN) 2 HIGH July 26, 1993
22108 4275 Ames OPTIMATE 6403 Urea (BUN) 2 HIGH July 26, 1993
22118 7378 Beckman Manual Spectrophotometric Test Procedure 6403 Urea (BUN) 2 HIGH July 26, 1993
22162 13216 DMA Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22172 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 6403 Urea (BUN) 2 HIGH July 26, 1993
22187 16010 Electronucleonics FLEXIGEM 6403 Urea (BUN) 2 HIGH July 26, 1993
22193 K960115 25259 HiChem BUN/Urea Reagent Kit (manual) 6403 Urea (BUN) 2 HIGH June 7, 1996
22194 K934533 25212 Horizon Blood Urea Nitrogen (BUN) (manual) 6403 Urea (BUN) 2 HIGH April 28, 1995
22197 28157 Instrumentation Laboratory IL 504 6403 Urea (BUN) 2 HIGH July 26, 1993
22198 28158 Instrumentation Laboratory IL 508 6403 Urea (BUN) 2 HIGH July 26, 1993
22206 28184 Instrumentation Laboratory Multistat III Plus 6403 Urea (BUN) 2 HIGH July 26, 1993
22227 34051 King Diagnostics Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22240 40126 Mallinckrodt Serometer 370 6403 Urea (BUN) 2 HIGH July 26, 1993
22241 40124 Medical Analysis Systems RefLab Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22242 40118 Meditech Diagnostic System Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22279 49064 Pointe Scientific 180 Chemistry Analyzer 6403 Urea (BUN) 2 HIGH July 26, 1993
22281 K923506 55106 Randox Laboratories Test Kit 6403 Urea (BUN) 2 HIGH January 26, 1996
22282 55075 Reagents Applications RAICHEM Test Kit (manual) 6403 Urea (BUN) 2 HIGH July 26, 1993
22309 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 6403 Urea (BUN) 2 HIGH July 26, 1993
22310 58187 Seradyn Quick-Chem II 6403 Urea (BUN) 2 HIGH July 26, 1993
22311 58185 Seragen StatEase 6403 Urea (BUN) 2 HIGH July 26, 1993
22312 58051 Sigma Diagnostics Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22313 58195 SmithKline ESKALAB-CCS 6403 Urea (BUN) 2 HIGH July 26, 1993
22314 58210 Stanbio Premiere 6403 Urea (BUN) 2 HIGH July 26, 1993
22315 58157 Stanbio Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22316 58230 Sterling Diagnostics Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22318 K882938 61377 TECO Diagnostics TC 84 6403 Urea (BUN) 2 HIGH November 19, 1998
22319 K863925 61403 TECO Diagnostics Urea Nitrogen (BUN) Reagent Set (manual) 6403 Urea (BUN) 2 HIGH March 26, 1999
22320 61044 TRACE Scientific Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22331 61014 Technicon SMA 12/60 6403 Urea (BUN) 2 HIGH July 26, 1993
22332 61015 Technicon SMA 6/60 6403 Urea (BUN) 2 HIGH July 26, 1993
22333 61016 Technicon SMAC 6403 Urea (BUN) 2 HIGH July 26, 1993
22334 61045 Technicon SMAC 2 6403 Urea (BUN) 2 HIGH July 26, 1993
22335 61046 Technicon SMAC 3 6403 Urea (BUN) 2 HIGH July 26, 1993
22337 70102 Wako Autokit 6403 Urea (BUN) 2 HIGH July 26, 1993
22339 70115 Wako Urea Nitrogen Test Kit 6403 Urea (BUN) 2 HIGH July 26, 1993
22342 4035 Abbott Bichromatic ABA 100 6404 Uric Acid 2 HIGH July 26, 1993
22343 K955496 4036 Abbott Bichromatic ABA 200 6404 Uric Acid 2 HIGH December 13, 1996
22344 4267 Abbott Bichromatic ABA 50 6404 Uric Acid 2 HIGH July 26, 1993
22357 4143 American Monitor KDA 6404 Uric Acid 2 HIGH July 26, 1993
22359 4275 Ames OPTIMATE 6404 Uric Acid 2 HIGH July 26, 1993
22407 13216 DMA Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22417 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 6404 Uric Acid 2 HIGH July 26, 1993
22432 16010 Electronucleonics FLEXIGEM 6404 Uric Acid 2 HIGH July 26, 1993
22437 K880277 25213 Horizon Uric Acid (manual) 6404 Uric Acid 2 HIGH April 28, 1995
22444 28183 Instrumentation Laboratory Multistat III 6404 Uric Acid 2 HIGH July 26, 1993
22475 40126 Mallinckrodt Serometer 370 6404 Uric Acid 2 HIGH July 26, 1993
22476 40124 Medical Analysis Systems RefLab Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22477 40118 Meditech Diagnostic System Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22502 49064 Pointe Scientific 180 Chemistry Analyzer 6404 Uric Acid 2 HIGH July 26, 1993
22504 55075 Reagents Applications RAICHEM Test Kit (manual) 6404 Uric Acid 2 HIGH July 26, 1993
22529 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 6404 Uric Acid 2 HIGH July 26, 1993
22530 58187 Seradyn Quick-Chem II 6404 Uric Acid 2 HIGH July 26, 1993
22531 58185 Seragen StatEase 6404 Uric Acid 2 HIGH July 26, 1993
22532 58051 Sigma Diagnostics Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22533 58195 SmithKline ESKALAB-CCS 6404 Uric Acid 2 HIGH July 26, 1993
22534 58210 Stanbio Premiere 6404 Uric Acid 2 HIGH July 26, 1993
22535 58157 Stanbio Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22536 58230 Sterling Diagnostics Test Kit 6404 Uric Acid 2 HIGH July 26, 1993
22537 K923414 58260 Synermed Test Kit 6404 Uric Acid 2 HIGH November 22, 1993
22538 K882938 61377 TECO Diagnostics TC 84 6404 Uric Acid 2 HIGH November 19, 1998
22539 K863924 61422 TECO Diagnostics Uric Acid Reagent Set (manual) 6404 Uric Acid 2 HIGH March 26, 1999
22550 61014 Technicon SMA 12/60 6404 Uric Acid 2 HIGH July 26, 1993
22551 61016 Technicon SMAC 6404 Uric Acid 2 HIGH July 26, 1993
22552 61045 Technicon SMAC 2 6404 Uric Acid 2 HIGH July 26, 1993
22553 61046 Technicon SMAC 3 6404 Uric Acid 2 HIGH July 26, 1993
22555 70102 Wako Autokit 6404 Uric Acid 2 HIGH July 26, 1993
22558 46114 Oxford Qualitative Stone Analysis Set 6407 Urinary Calculi 2 HIGH July 26, 1993
23006 28184 Instrumentation Laboratory Multistat III Plus 6409 Urokinase 2 HIGH July 26, 1993
23008 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6717 Valine 2 HIGH November 10, 1994
23009 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 6717 Valine 2 HIGH May 26, 1995
23013 4275 Ames OPTIMATE 6701 Valproic Acid 7 HIGH July 26, 1993
23014 4156 Ames TDA 6701 Valproic Acid 7 HIGH July 26, 1993
23052 28183 Instrumentation Laboratory Multistat III 6701 Valproic Acid 7 HIGH July 26, 1993
23053 28184 Instrumentation Laboratory Multistat III Plus 6701 Valproic Acid 7 HIGH July 26, 1993
23081 58082 Syva Emit Test Kit 6701 Valproic Acid 7 HIGH July 26, 1993
23154 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 6710 Vanillylmandelic Acid (VMA) 6 HIGH August 23, 1996
23155 7279 Bio-Rad HPLC 6710 Vanillylmandelic Acid (VMA) 6 HIGH July 26, 1993
23156 K934977 16043 esa Coulochem Electrode Array System (CEAS) 6710 Vanillylmandelic Acid (VMA) 6 HIGH June 10, 1994
23158 7328 BioWhittaker FIAX System 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23159 7351 BioWhittaker VARICELISA II 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23160 7352 BioWhittaker VARICELLA STAT 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23161 K981867 13504 Diamedix Immunosimplicity (Is)-VZV IgG (manual) 6704 Varicella-Zoster Virus Antibodies 3 HIGH October 2, 1998
23163 13247 Diamedix VZV Microassay 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23164 K941046 22170 Gull Laboratories VZV IgG ELISA Test 6704 Varicella-Zoster Virus Antibodies 3 HIGH September 1, 1995
23165 K875358 22101 Gull Laboratories VZV IgG IFA Test 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23166 K875358 22125 Gull Laboratories VZV IgM IFA Test 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23167 28227 Incstar Clin-ELISA Varicella zoster IgG 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23168 K990141 37161 Light Diagnostics SimulFluor HSV/VZV IFA (direct antigen) 6704 Varicella-Zoster Virus Antibodies 3 HIGH January 26, 2000
23169 K990141 37162 Light Diagnostics SimulFluor HSV/VZV IFA (including culture) 6704 Varicella-Zoster Virus Antibodies 3 HIGH January 26, 2000
23170 49030 Pharmacia Varicella-Zoster Virus IgG ELISA 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23171 49029 Pharmacia Varicella-Zoster Virus IgM ELISA 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23172 K972295 52064 Quest International SeraQuest VZV IgG (manual/qualitative) 6704 Varicella-Zoster Virus Antibodies 3 HIGH December 5, 1997
23173 K972295 52065 Quest International SeraQuest VZV IgG (manual/semi-quantitative) 6704 Varicella-Zoster Virus Antibodies 3 HIGH December 5, 1997
23175 K972295 52066 Quest International SeraQuest VZV IgG {Hyperion HyPrep Plus} (manual calculations) 6704 Varicella-Zoster Virus Antibodies 3 HIGH December 5, 1997
23177 58199 Sigma Diagnostics SIA VZV IgG 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23179 67029 Virgo Varicella-zoster Antibody IFA Test 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23181 79028 Zeus Scientific VZ IgG IFA 6704 Varicella-Zoster Virus Antibodies 3 HIGH July 26, 1993
23183 K951799 37104 Light Diagnostics Varicella-zoster Virus Direct IFA (direct Ag) 6705 Varicella-Zoster viruses 10 HIGH May 3, 1996
23184 K951799 37105 Light Diagnostics Varicella-zoster Virus Direct IFA (including culture) 6705 Varicella-Zoster viruses 10 HIGH May 3, 1996
23185 46083 Ortho Varicella-Zoster Virus ID by DFA (direct Ag) 6705 Varicella-Zoster viruses 10 HIGH July 26, 1993
23186 K942743 67093 Viro Varicella-Zoster Virus ID Reagent (direct Ag) 6705 Varicella-Zoster viruses 10 HIGH December 23, 1994
23187 K942743 67094 Viro Varicella-Zoster Virus ID Reagent (including cell culture) 6705 Varicella-Zoster viruses 10 HIGH December 23, 1994
23191 4365 All Manual Nucleic Acid Analysis Test Systems & Procedures 6706 Viruses 10 HIGH July 26, 1993
23192 4134 All Viral Cell Culture Identification 6706 Viruses 10 HIGH July 26, 1993
23201 7106 Becton Dickinson SimulTRAC 6707 Vitamin B12 2 HIGH July 26, 1993
23202 7108 Becton Dickinson SimulTRAC SNB 6707 Vitamin B12 2 HIGH July 26, 1993
23206 7354 Bio-Rad Quantaphase 6707 Vitamin B12 2 HIGH July 26, 1993
23207 K935286 7532 Bio-Rad Quantaphase II 6707 Vitamin B12 2 HIGH September 30, 1994
23216 10051 Ciba Corning Magic (MGC) 6707 Vitamin B12 2 HIGH July 26, 1993
23217 10054 Ciba Corning Magic Boil 6707 Vitamin B12 2 HIGH July 26, 1993
23218 10055 Ciba Corning Magic Lite 6707 Vitamin B12 2 HIGH July 26, 1993
23219 10057 Ciba Corning Magic/NB (no boil) 6707 Vitamin B12 2 HIGH July 26, 1993
23221 10062 Clinical Assays NO-Boil 6707 Vitamin B12 2 HIGH July 26, 1993
23225 13032 Diagnostic Products Corp. Dualcount Charcoal 6707 Vitamin B12 2 HIGH July 26, 1993
23226 13033 Diagnostic Products Corp. Dualcount No Boil 6707 Vitamin B12 2 HIGH July 26, 1993
23227 13034 Diagnostic Products Corp. Dualcount Solid Phase Boil 6707 Vitamin B12 2 HIGH July 26, 1993
23228 13041 Diagnostic Products Corp. Solid Phase No Boil 6707 Vitamin B12 2 HIGH July 26, 1993
23229 40083 Micromedic Combostat II 6707 Vitamin B12 2 HIGH July 26, 1993
23251 K955561 4667 ALPCO Vitamin B6 3H REA 6718 Vitamin B6 2 HIGH June 21, 1996
23311 10103 Coulter A 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23316 10185 Coulter B 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23319 10180 Coulter Counter Model A 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23320 10186 Coulter D 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23321 10104 Coulter D2 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23322 10109 Coulter FN 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23357 K952308 10325 Coulter Z1 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH November 3, 1995
23358 K991070 10479 Coulter Z2 Analyzer 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 9, 1999
23359 10126 Coulter ZBI 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23360 10127 Coulter ZBI6 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23361 10128 Coulter ZF 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23362 10130 Coulter ZM 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
23364 13277 DMA H3-HCT 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23365 13278 DMA H3-Hgb 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23366 13280 DMA H5 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23367 13279 DMA H5-M 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23368 13281 DMA H7 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23396 40171 Mallinckrodt H5-M 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23397 40169 Mallinckrodt S-610 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23398 40170 Mallinckrodt S-630 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23399 40172 Mallinckrodt S-650 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23441 58305 SmithKline ESKALAB-CHS H10 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23442 58300 SmithKline ESKALAB-CHS H3-HCT 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23443 58301 SmithKline ESKALAB-CHS H3-Hgb 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23444 58303 SmithKline ESKALAB-CHS H5 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23445 58302 SmithKline ESKALAB-CHS H5-M 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23446 58304 SmithKline ESKALAB-CHS H7 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23487 61127 Texas International Laboratories H10 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23489 61121 Texas International Laboratories H3-HCT 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23490 61122 Texas International Laboratories H3-Hgb 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23491 61124 Texas International Laboratories H5 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23492 61125 Texas International Laboratories H7 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
23516 4127 All Manual WBC Diff Procedures (with interpretation of atypical cells) 7001 White Blood Cell Differential (WBC Diff) 4 HIGH July 26, 1993
23569 K925670 28445 IMI MICRO21 (with interpretation of atypical/immature cells) 7001 White Blood Cell Differential (WBC Diff) 4 HIGH August 16, 1996
23571 K973050 28517 IMI MICRO21 {with WBC Estimate} (with interpretation of abnormal/immature cells) 7001 White Blood Cell Differential (WBC Diff) 4 HIGH February 27, 1998
23572 K953116 28408 IRIS The White IRIS Leukocyte Differential Analyzer 7001 White Blood Cell Differential (WBC Diff) 4 HIGH May 17, 1996
23617 25129 Haemoscope Thromboelastograph (calculated result) 7003 Whole Blood Clotting Time 4 HIGH July 26, 1993
23620 37058 Logos elvi 816 Bi Clot (calculated result) 7003 Whole Blood Clotting Time 4 HIGH July 26, 1993
23622 58253 Sienco SONOCLOT Coagulation Analyzer (calculated result) 7003 Whole Blood Clotting Time 4 HIGH July 26, 1993
23624 58254 Sienco SONOCLOT II Surgical Analyzer (calculated result) 7003 Whole Blood Clotting Time 4 HIGH July 26, 1993
23626 4059 Abbott Quantum II System (including culture) 7601 Yeast 12 HIGH July 26, 1993
23627 4219 Analytab Yeast Ident (including culture) 7601 Yeast 12 HIGH July 26, 1993
23628 7023 Baxter AutoSCAN Walk/Away (including culture) 7601 Yeast 12 HIGH July 26, 1993
23629 7042 Baxter MicroScan AutoSCAN 4 (including culture) 7601 Yeast 12 HIGH July 26, 1993
23630 10025 Carr-Scarborough C. albicans Disc Screening Kit (including culture) 7601 Yeast 12 HIGH July 26, 1993
23632 K943621 28383 Innovative Diagnostic Systems RapID Yeast Plus System (including culture) 7601 Yeast 12 HIGH February 24, 1995
23633 40054 Medical Wire Equip. MicroRing YT (including culture) 7601 Yeast 12 HIGH July 26, 1993
23635 K960090 55206 Remel Calcofluor White Stain Kit 7601 Yeast 12 HIGH May 17, 1996
23636 67035 Vitek Systems VITEK (including culture) 7601 Yeast 12 HIGH July 26, 1993
23650 55070 Ramco Laboratories CAND-TEC Candida Detection System (direct Ag) 7603 Yeast, Candida only 12 HIGH July 26, 1993
23653 7040 Baxter MYCO-Immune Cryptococcal LA (direct Ag) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
23654 28106 Immuno-Mycologics Latex-Crypto (direct Ag) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
23657 K930418 61136 Trinity Laboratories CRYPTO-LEX System 7604 Yeast, Cryptococcus only 12 HIGH June 10, 1994
23658 70076 Wampole Crypto-LA Test (direct Ag) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
23659 7204 Bio-Medical ANI Yersinia Test (including culture) 7605 Yersinia enterocolitica 8 HIGH July 26, 1993
23660 70101 Wako Zn Test Kit 7902 Zinc 2 HIGH July 26, 1993
23661 16020 esa Model 3010A Trace Metals Analyzer 7902 Zinc 2 HIGH July 26, 1993
23679 10340 Chiron Diagnostics 158 4982 pH 2 HIGH November 15, 1996
23680 10341 Chiron Diagnostics 168 4982 pH 2 HIGH November 15, 1996
23694 10032 Ciba Corning 168 4982 pH 2 HIGH July 26, 1993
23792 K942087 4662 American Diagnostica Rellplate vWF EID Kit 6708 von Willebrand Factor 4 HIGH April 26, 1996
23793 7194 Bio/Data PAP-4 6708 von Willebrand Factor 4 HIGH July 26, 1993
23794 7193 Bio/Data PAP-4C 6708 von Willebrand Factor 4 HIGH July 26, 1993
23795 7221 Biopool vWF EID Kit 6708 von Willebrand Factor 4 HIGH July 26, 1993
23796 13133 Diagnostica Stago ASSERACHROM vWF 6708 von Willebrand Factor 4 HIGH July 26, 1993
23797 13140 Diagnostica Stago Assera-Plate vWF 6708 von Willebrand Factor 4 HIGH July 26, 1993
23798 22109 General Diagnostics Von Willebrand Factor Assay 6708 von Willebrand Factor 4 HIGH July 26, 1993
23801 55067 Ramco Laboratories Spectro vWF 6708 von Willebrand Factor 4 HIGH July 26, 1993
23802 K983107 55586 Ramco Laboratories VFE 6708 von Willebrand Factor 4 HIGH April 2, 1999
23803 K972005 55287 Reaads Medical Products von Willebrand Factor Antigen Test Kit 6708 von Willebrand Factor 4 HIGH March 6, 1998
23804 K962825 58445 Shield Diagnostics von Willebrand Factor Activity Kit 6708 von Willebrand Factor 4 HIGH April 25, 1997
23805 K972116 7824 Behring Coagulation Timer (BCT) 6711 von Willebrand Factor (Ristocetin Cofactor) 4 HIGH December 5, 1997
23806 K945414 10282 Chrono-log Ristocetin Cofactor Assay 6711 von Willebrand Factor (Ristocetin Cofactor) 4 HIGH January 20, 1995
23807 25029 Helena Laboratories PACKS-4 6711 von Willebrand Factor (Ristocetin Cofactor) 4 HIGH July 26, 1993
23808 55072 Ramco Laboratories vWF Multimer Immunoblot 6709 von Willebrand Multimers 4 HIGH July 26, 1993
23809 K953567 28374 Incstar 25-Hydroxyvitamin D 125I RIA Kit 110 25-Hydroxyvitamin D (25-OH-D) 6 HIGH October 4, 1996
23811 K934977 16043 esa Coulochem Electrode Array System (CEAS) 101 5-Hydroxyindolacetic Acid, Urine (5-HIAA) 6 HIGH June 10, 1994
23818 K915705 61395 TECO Diagnostics Acid Phosphatase Reagent Set (manual) 407 Acid Phosphatase 2 HIGH March 26, 1999
23819 10003 Cambridge Biotech Adenoclone-EIA (including cell culture/visual) 410 Adenovirus 10 HIGH July 26, 1993
23823 4144 American Monitor Parallel 414 Albumin 2 HIGH July 26, 1993
23833 58157 Stanbio Test Kit 414 Albumin 2 HIGH July 26, 1993
23842 25089 Helena Laboratories Titan Gel Alkaline Phosphatase (HR) 469 Alkaline Phosphatase Isoenzymes 2 HIGH July 26, 1993
23843 K940810 10376 Chiron Diagnostics ACS 180 Plus 423 Alpha-Fetoprotein - Maternal Serum 2 HIGH February 20, 1998
23848 K951154 7722 Beckman Synchron CX 4 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH December 1, 1995
23862 58015 Scimedx Anti-adrenal Test System 430 Anti-Adrenal Antibodies 3 HIGH July 26, 1993
23863 K983692 61383 The Binding Site BINDAZYME Anticardiolipin IgG EIA 434 Anti-Cardiolipin Antibodies 3 HIGH February 12, 1999
23864 7328 BioWhittaker FIAX System 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
23865 40007 MarDx Anti-nDNA Antibody Test System 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
23866 40008 MarDx Autoimmune IFA Screening Test System 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
23867 7145 BioHyTech EIA Kit 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
23868 K940229 16074 elias usa Synelisa ANA-8 Screen (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH November 10, 1994
23869 K931495 25148 Helix Diagnostics Anti-SS-A/Ro EIA 446 Anti-SS-A/Ro 3 HIGH November 22, 1993
23870 34046 Kallestad SSA/SSB ENA 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
23871 28126 Immuno Concepts Sm/RNP Ab Test System 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
23872 58020 Scimedx ENA Detect II Test System 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
23873 37066 LAbor COA Data 3000 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
23880 40118 Meditech Diagnostic System Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
23881 70102 Wako Autokit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
23886 13031 Diagnostic Products Corp. Double Antibody 702 Benzodiazepines 7 HIGH July 26, 1993
23887 28183 Instrumentation Laboratory Multistat III 702 Benzodiazepines 7 HIGH July 26, 1993
23895 49064 Pointe Scientific 180 Chemistry Analyzer 704 Bilirubin, Direct 2 HIGH July 26, 1993
23906 K881241 25199 Horizon Total Bilirubin (manual) 706 Bilirubin, Total 2 HIGH April 28, 1995
23910 58185 Seragen StatEase 706 Bilirubin, Total 2 HIGH July 26, 1993
23912 10340 Chiron Diagnostics 158 708 Blood Gases 2 HIGH November 15, 1996
23919 4143 American Monitor KDA 1005 Calcium, Total 2 HIGH July 26, 1993
23926 7078 Becton Dickinson BBL Campyslide Test (including culture) 1006 Campylobacter 8 HIGH July 26, 1993
23943 K960392 7792 Bio-Rad CDM System {Bio-Rad HPLC} 1056 Catecholamines, Plasma 6 HIGH August 23, 1996
23956 55075 Reagents Applications RAICHEM Test Kit (manual) 1018 Chloride 2 HIGH July 26, 1993
23957 K883386 61405 TECO Diagnostics Chloride Reagent Set (manual) 1018 Chloride 2 HIGH March 26, 1999
23959 4143 American Monitor KDA 1020 Cholesterol 2 HIGH July 26, 1993
23975 K924098 28297 Instrumentation Laboratory MCL 2 Coagulation Analyzer 1044 Coagulation Factors 4 HIGH November 22, 1993
23976 46074 Ortho Koagulab 16S 1044 Coagulation Factors 4 HIGH July 26, 1993
23977 K964139 61283 TOA Medical Electronics CA-6000 1044 Coagulation Factors 4 HIGH April 11, 1997
23981 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 1029 Complement C3 3 HIGH July 26, 1993
23987 13175 Diagnostic Systems Active Cortisol EIA Kit 1032 Cortisol 6 HIGH July 26, 1993
23990 K930732 70159 Wallac Oy DELFIA Cortisol Kit 1032 Cortisol 6 HIGH November 22, 1993
23991 K945367 10046 Ciba Corning ACS 180 1095 Cortisol, Urine (extraction procedure) 6 HIGH May 19, 1995
24011 22150 General Biometrics Cytomegalovirus IgG IFA Test 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
24017 10051 Ciba Corning Magic (MGC) 1304 Digoxin 7 HIGH July 26, 1993
24023 58082 Syva Emit Test Kit 1305 Disopyramide 7 HIGH July 26, 1993
24024 K935730 22168 Gull Laboratories EBNA IgG ELISA (quantitative) 1603 Epstein-Barr virus Antibodies 3 HIGH September 29, 1995
24025 49021 Pharmacia Epstein Barr Virus Viral Capsid Antigen IgG ELISA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
24028 4036 Abbott Bichromatic ABA 200 1608 Ethanol (Alcohol) 7 HIGH July 26, 1993
24033 58190 Syva Qstat/Qst System 1609 Ethosuximide 7 HIGH July 26, 1993
24037 13111 Diagnostic Products Corp. Milenia 1902 Ferritin 2 HIGH July 26, 1993
24038 55088 Ramco Laboratories Spectro Ferritin 1902 Ferritin 2 HIGH July 26, 1993
24046 13033 Diagnostic Products Corp. Dualcount No Boil 1907 Folate (Folic acid) 2 HIGH July 26, 1993
24048 10061 Clinical Assays GammaDab 1908 Follicle Stimulating Hormone (FSH) 6 HIGH July 26, 1993
24051 4143 American Monitor KDA 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
24056 10061 Clinical Assays GammaDab 2202 Gentamicin 7 HIGH July 26, 1993
24061 K955897 61263 TechLab Crypto/Giardia-Cel IF Test 2222 Giardia lamblia 11 HIGH November 8, 1996
24069 40118 Meditech Diagnostic System Test Kit 2203 Glucose 2 HIGH July 26, 1993
24074 58164 Sherwood Medical Auto/Stat Kit 2203 Glucose 2 HIGH July 26, 1993
24075 K863926 61412 TECO Diagnostics Glucose Reagent Set (manual) 2203 Glucose 2 HIGH March 26, 1999
24077 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 2218 Glutamine 2 HIGH November 10, 1994
24079 25078 Helena Laboratories Titan Gel-PC GLYCO-Heme System 2204 Glycosylated Hemoglobin (Hgb A1C) 2 HIGH July 26, 1993
24088 10115 Coulter Optichem 100 2550 HDL Cholesterol 2 HIGH July 26, 1993
24089 13087 Du Pont Dimension AR 2550 HDL Cholesterol 2 HIGH July 26, 1993
24092 46087 Olympus AU 5121 2550 HDL Cholesterol 2 HIGH September 1, 1994
24094 46129 Olympus Reply/AU 560 2550 HDL Cholesterol 2 HIGH July 26, 1993
24096 58042 Seradyn Manual Determination (spectrophotometric/colorimetric) 2550 HDL Cholesterol 2 HIGH July 26, 1993
24097 10030 Cellular Products Retro-Tek HTLV-1 ELISA 2508 HTLV Antibodies 3 HIGH July 26, 1993
24107 40172 Mallinckrodt S-650 2514 Hematocrit 4 HIGH September 1, 1994
24111 58302 SmithKline ESKALAB-CHS H5-M 2514 Hematocrit 4 HIGH September 1, 1994
24119 13281 DMA H7 2515 Hemoglobin 4 HIGH September 1, 1994
24125 58305 SmithKline ESKALAB-CHS H10 2515 Hemoglobin 4 HIGH September 1, 1994
24127 28180 Isolab Quik-Sep Hemoglobin A2 Test System 2535 Hemoglobin A2 2 HIGH July 26, 1993
24130 K943515 4584 American Bioproducts ROTACHROM Heparin 2518 Heparin 4 HIGH September 8, 1995
24131 K923499 7526 Biopool Spectrolyse Heparin 2518 Heparin 4 HIGH September 30, 1994
24132 28197 Instrumentation Laboratory IL ACL 300 Plus 2518 Heparin 4 HIGH July 26, 1993
24133 46030 Organon Teknika Hepanostika Anti-HAV IgM Microelisa System 2519 Hepatitis A Virus Antibody 3 HIGH July 26, 1993
24134 46070 Ortho HBc ELISA 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
24135 52005 Quidel CIC-Raji Cell Replacement EIA 2801 Immune complexes (CIC) 3 HIGH July 26, 1993
24137 7246 Behring S-partigen Kit 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
24146 K933972 10256 Crestat Diagnostics N-Assay TIA IgG (manual) 2806 Immunoglobulins IgG 3 HIGH June 10, 1994
24155 10166 Corning Medical IMMO PHASE RIA 2812 Insulin 6 HIGH July 26, 1993
24156 4036 Abbott Bichromatic ABA 200 2814 Iron 2 HIGH July 26, 1993
24161 K933329 34051 King Diagnostics Test Kit 2814 Iron 2 HIGH May 20, 1994
24164 4035 Abbott Bichromatic ABA 100 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
24166 13018 Dade Neutr-AB Reagent - titration 2816 Isohemagglutinins 5 HIGH July 26, 1993
24167 25039 Helena Laboratories Titan IV Double Diffusion 3402 Kappa Light Chains 3 HIGH July 26, 1993
24171 K964063 61310 Technicon RA 500 {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
24173 7378 Beckman Manual Spectrophotometric Test Procedure 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
24174 13216 DMA Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
24177 25091 Helena Laboratories Titan Gel Iso-Dot LD Flur (clear) 3721 Lactate Dehydrogenase Isoenzymes 2 HIGH July 26, 1993
24183 58051 Sigma Diagnostics Test Kit 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
24184 7382 Beckman ICS II 3705 Lambda Light Chains 3 HIGH July 26, 1993
24185 58454 Scimedx Legionella Test Kit/DFA (including culture) 3706 Legionella 8 HIGH August 1, 1997
24192 7366 Beckman Paragon Lipoprotein Electrophoresis Kit 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
24194 7062 Beckman Flame Photometer 3712 Lithium 7 HIGH July 26, 1993
24196 49006 Perkin Elmer Atomic Absorption Spectrophotometer 3712 Lithium 7 HIGH July 26, 1993
24198 K922745 10331 Coulter EPICS XL-MCL 3766 Lymphocytes, CD3/CD4 3 HIGH May 10, 1996
24203 40118 Meditech Diagnostic System Test Kit 4002 Magnesium 2 HIGH July 26, 1993
24220 K903123 55248 RAIChem Microalbumin Reagent (manual) 4019 Microalbumin 2 HIGH August 15, 1997
24225 K921412 58230 Sterling Diagnostics Test Kit 4026 Microprotein, CSF 2 HIGH November 22, 1993
24227 13216 DMA Test Kit 4027 Microprotein, Urine 2 HIGH September 1, 1994
24229 58051 Sigma Diagnostics Test Kit 4027 Microprotein, Urine 2 HIGH July 26, 1993
24231 28183 Instrumentation Laboratory Multistat III 4301 N-Acetylprocainamide (NAPA) 7 HIGH July 26, 1993
24241 7192 BioAutoMed ASCA 4605 Oxalate 2 HIGH July 26, 1993
24242 28183 Instrumentation Laboratory Multistat III 4605 Oxalate 2 HIGH July 26, 1993
24244 10340 Chiron Diagnostics 158 4983 PCO2 2 HIGH November 15, 1996
24245 10032 Ciba Corning 168 4983 PCO2 2 HIGH July 26, 1993
24254 7359 Baxter Bartels Viral Respiratory Kit (including cell culture) 4959 Parainfluenza 1 10 HIGH September 1, 1994
24255 K942369 28351 ImmunoDiagnostic Systems Gamma-BCT Intact PTH 4924 Parathyroid Hormone - Intact 6 HIGH November 10, 1994
24257 7382 Beckman ICS II 4902 Phenobarbital 7 HIGH July 26, 1993
24262 7382 Beckman ICS II 4903 Phenytoin 7 HIGH July 26, 1993
24265 28184 Instrumentation Laboratory Multistat III Plus 4903 Phenytoin 7 HIGH July 26, 1993
24278 10150 Chrono-log Aggregometer 440VS 4928 Platelet Aggregation 4 HIGH July 26, 1993
24279 28088 Immucor Capture-P Ready-Screen 4927 Platelet Antibody - detection 3 HIGH July 26, 1993
24284 10127 Coulter ZBI6 4908 Platelet Count 4 HIGH July 26, 1993
24286 58306 SmithKline ESKALAB-CHS Plt-4 4908 Platelet Count 4 HIGH September 1, 1994
24288 61127 Texas International Laboratories H10 4908 Platelet Count 4 HIGH September 1, 1994
24310 25111 Helena Laboratories Chromogenic Systems Analyzer 1200 4935 Prekallikrein 4 HIGH July 26, 1993
24314 4156 Ames TDA 4913 Procainamide 7 HIGH July 26, 1993
24319 70153 Wallac Oy DELFIA Progesterone Kit 4914 Progesterone 6 HIGH September 1, 1994
24321 28214 ICN IMMUNOCHEM PRL-MW ELISA 4915 Prolactin 6 HIGH July 26, 1993
24329 37033 LAbor COA Screener 4929 Protein C 4 HIGH July 26, 1993
24330 K922201 55040 Roche Diagnostics Cobas FARA 4929 Protein C 4 HIGH November 22, 1993
24331 25117 Helena Laboratories REP SPE 4920 Protein Fractions 2 HIGH July 26, 1993
24332 K930327 28073 Instrumentation Laboratory IL ACL 100 4930 Protein S 4 HIGH November 22, 1993
24342 58051 Sigma Diagnostics Test Kit 4941 Pyruvate 2 HIGH July 26, 1993
24353 K961277 79052 Zeus Scientific Rheumatoid Factor (RF) IgM ELISA 5508 Rheumatoid Factor (RF) 3 HIGH November 8, 1996
24355 K960367 28473 Incstar Rubella IgG ELISA Kit 5510 Rubella Antibodies 3 HIGH January 24, 1997
24357 4035 Abbott Bichromatic ABA 100 5801 Salicylates 7 HIGH July 26, 1993
24363 4036 Abbott Bichromatic ABA 200 5805 Sodium 2 HIGH July 26, 1993
24377 55007 Radiometer Flame Photometer 5805 Sodium 2 HIGH July 26, 1993
24379 K934383 49116 Pro-Lab Prolex Streptococcal Grouping Latex (including culture) 5813 Streptococcus, group D 8 HIGH February 3, 1995
24380 K942093 55139 Remel RIM Strep Grouping LA Test (including culture) 5814 Streptococcus, group F 8 HIGH December 9, 1994
24383 K973900 34105 KMI Diagnostics Testosterone ELISA 6102 Testosterone 6 HIGH March 26, 1999
24385 7188 Bio-Chem Laboratory Systems ATAC 2000/2100 6104 Theophylline 7 HIGH July 26, 1993
24393 7102 Becton Dickinson Monoclonal Solid Phase Coated Tube 6109 Thyroxine (T4) 6 HIGH July 26, 1993
24394 K950588 7635 Biomerica T4 Microwell EIA 6109 Thyroxine (T4) 6 HIGH July 7, 1995
24403 K951014 28367 Isolab Fluoroscan II Neonatal Chemistry System 6123 Thyroxine (T4), Neonatal 6 HIGH February 6, 1998
24408 7381 Beckman ICS 6114 Transferrin 2 HIGH July 26, 1993
24419 58187 Seradyn Quick-Chem II 6118 Triglyceride 2 HIGH July 26, 1993
24422 10052 Ciba Corning Magic (MGC) (25-35 normal range) 6120 Triiodothyronine Uptake (T3U) (TU) 6 HIGH July 26, 1993
24430 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 6403 Urea (BUN) 2 HIGH November 10, 1994
24434 K952742 40219 MeDiTech Blood Urea Nitrogen (manual) 6403 Urea (BUN) 2 HIGH August 18, 1995
24439 4144 American Monitor Parallel 6404 Uric Acid 2 HIGH July 26, 1993
24444 43055 Nycomed Nycotest 6404 Uric Acid 2 HIGH July 26, 1993
24446 K923503 55106 Randox Laboratories Test Kit 6404 Uric Acid 2 HIGH September 30, 1994
24459 7107 Becton Dickinson SimulTRAC S 6707 Vitamin B12 2 HIGH July 26, 1993
24463 13283 DMA H10 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
24466 4266 All India Ink Preparations 7601 Yeast 12 HIGH July 26, 1993
24472 K953587 16123 elias usa Varelisa PR3-ANCA EIA (semi-quantitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH February 9, 1996
24474 55106 Randox Laboratories Test Kit 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
24477 K951710 7718 Boehringer Mannheim Hitachi 704 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
24478 K951710 7719 Boehringer Mannheim Hitachi 717 {CEDIA DAU} (manual curve) 702 Benzodiazepines 7 HIGH December 1, 1995
24486 K944562 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
24488 28184 Instrumentation Laboratory Multistat III Plus 1015 Ceruloplasmin 2 HIGH July 26, 1993
24492 4325 Alexon-Trend ProSpecT Cryptosporidium Microtiter (direct Ag/visual) 1109 Cryptosporidium 11 HIGH February 3, 1995
24499 7247 Becton Dickinson MAb Solid Phase Component System 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
24500 10055 Ciba Corning Magic Lite 2502 HCG, Beta, Serum, Quantitative 6 HIGH July 26, 1993
24511 K923445 13342 DAKO Helicobacter pylori IgG Test Kit 2513 Helicobacter pylori Antibodies 3 HIGH March 3, 1995
24518 10127 Coulter ZBI6 2515 Hemoglobin 4 HIGH July 26, 1993
24524 7192 BioAutoMed ASCA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 26, 1993
24527 K884020 10330 Coulter EPICS XL 3759 Lymphocytes, CD19 3 HIGH May 10, 1996
24528 10253 Coulter Clone Immunophenotyping by Fluorescence Microscopy 3758 Lymphocytes, CD20 3 HIGH September 1, 1994
24529 K893853 10246 Coulter Epics Flow Cytometer 3764 Lymphocytes, CD8 3 HIGH September 1, 1994
24530 K894179 10330 Coulter EPICS XL 4040 Monocytes, CD14 (MY4) 3 HIGH May 10, 1996
24531 22130 Gen-Probe AccuProbe - M. gordonae (including culture) 4011 Mycobacterium gordonae 9 HIGH September 22, 1995
24552 25068 Helena Laboratories REP SPE Hi Res-15 Procedure 4920 Protein Fractions 2 HIGH July 26, 1993
24559 67083 Ventana DAB Detection Kit (tissue specimen) 6163 Tissue (Cell) Antigens 3 HIGH September 1, 1994
24560 K880918 13340 DAKO IDEIA Toxo-G 6113 Toxoplasma gondii Antibodies 3 HIGH March 3, 1995
24562 K932608 55130 Roche Diagnostics Cobas Core T3 EIA (manual) 6119 Triiodothyronine (T3) 6 HIGH June 10, 1994
24570 10031 Ciba Corning 158 4982 pH 2 HIGH July 26, 1993
24580 K993174 58606 Sysmex CA-6000 463 Alpha-2-Antiplasmin 4 HIGH January 27, 2000
24581 K992763 13548 Dade Behring Sysmex CA-500 Series 1044 Coagulation Factors 4 HIGH January 18, 2000
24584 K924006 28596 INTRACEL Bartels PRIMA Influenza A EIA (including cell culture) 2828 Influenza A 10 HIGH January 18, 2000
24585 K982307 70237 Wallac Neonatal Leucine Test Kit 3749 Leucine 2 HIGH January 26, 2000
24587 K990172 10495 Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 3761 Lymphocytes, CD4 3 HIGH January 7, 2000
24588 K982450 58600 Sebia Hydragel -Mini HR/HR Kit (manual) 4920 Protein Fractions 2 HIGH January 26, 2000
24600 28087 IBG Inverness Blood Grouping System 403 ABO group confirmation - Serum, Plasma 5 HIGH July 26, 1993
24624 K953981 46195 Ortho SynthASil APTT (manual) 409 Activated Partial Thromboplastin Time (APTT) 4 HIGH December 8, 1995
24625 K962968 7828 Behring ProC APC (manual) 526 Activated Protein C (APC) Resistance 4 HIGH January 3, 1997
24626 4201 Analytab API Quad Ferm + (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
24628 67035 Vitek Systems VITEK (including culture) 412 Aerobic &/or Anaerobic Organisms-unlimited sources 8 HIGH July 26, 1993
24630 4299 All Gram Stain Procedures - Other than Urethral/Endocervical 478 Aerobic/Anaerobic Organ.-Other than Ureth/Endocerv 8 HIGH July 26, 1993
24638 58157 Stanbio Test Kit 404 Alanine Aminotransferase (ALT) (SGPT) 2 HIGH July 26, 1993
24642 7382 Beckman ICS II 414 Albumin 2 HIGH July 26, 1993
24647 28184 Instrumentation Laboratory Multistat III Plus 414 Albumin 2 HIGH July 26, 1993
24653 61046 Technicon SMAC 3 414 Albumin 2 HIGH July 26, 1993
24657 K880307 25205 Horizon Alkaline Phosphatase (pNPP Rate) (manual) 416 Alkaline Phosphatase (ALP) 2 HIGH April 28, 1995
24664 58210 Stanbio Premiere 416 Alkaline Phosphatase (ALP) 2 HIGH July 26, 1993
24667 13208 Dexall Biomedical AllergEns ActiTip System 417 Allergen specific IgE 3 HIGH July 26, 1993
24668 K945748 25230 Hycor Specific IgE EIA 417 Allergen specific IgE 3 HIGH June 30, 1995
24670 7315 BioWhittaker 3M Allergen Specific IgG4 FAST Test 418 Allergen specific IgG 3 HIGH July 26, 1993
24671 34010 Kent Radial Immunodiffusion Test 420 Alpha-1-Acid Glycoprotein (orosomucoid) 3 HIGH July 26, 1993
24672 7119 Behring Nor-partigen Kit 421 Alpha-1-Antitrypsin 3 HIGH July 26, 1993
24674 K961579 4677 American Bioproducts STA Compact Analyzer 463 Alpha-2-Antiplasmin 4 HIGH November 1, 1996
24675 K981817 28543 Instrumentation Laboratory IL ACL 200 {Chromogenix Coamatic Plasmin Inhibitor} 463 Alpha-2-Antiplasmin 4 HIGH December 18, 1998
24678 25022 Hybritech Tandem-E 424 Alpha-Fetoprotein - Tumor Marker 3 HIGH July 26, 1993
24679 7378 Beckman Manual Spectrophotometric Test Procedure 419 Alpha-Hydroxybutyrate Dehydrogenase (HBDH) 2 HIGH July 26, 1993
24685 28184 Instrumentation Laboratory Multistat III Plus 425 Amikacin 7 HIGH July 26, 1993
24703 K943993 55375 Roche Diagnostics Hitachi 704 {CEDIA DAU} (manual curve) 428 Amphetamines 7 HIGH May 7, 1999
24712 K930678 25207 Horizon Amylase (manual) 429 Amylase 2 HIGH April 28, 1995
24719 K941091 58260 Synermed Test Kit 429 Amylase 2 HIGH September 30, 1994
24722 K963002 13429 Diagnostic Systems DSL-10-3800 ACTIVE Androstenedione EIA 460 Androstenedione 6 HIGH September 6, 1996
24725 4706 Arlington Scientific Cardiolipin ELISA 434 Anti-Cardiolipin Antibodies 3 HIGH April 18, 1997
24726 K933786 28328 IMMCO Diagnostics Anti-Cardiolipin IgG Antibody (ACA) Test 434 Anti-Cardiolipin Antibodies 3 HIGH March 17, 1995
24727 K952522 40247 MarDx Cardiolipin IgA EIA 434 Anti-Cardiolipin Antibodies 3 HIGH March 1, 1996
24728 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 487 Anti-Centromere Antibodies 3 HIGH June 10, 1994
24729 7345 BioWhittaker RheumELISA Kit 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
24730 K952567 10320 Cogent Diagnostics AUTOSTAT II Anti-dsDNA IgG (quantitative) 435 Anti-DNA Antibodies 3 HIGH March 7, 1997
24731 79002 Zeus Scientific Anti-DNA 435 Anti-DNA Antibodies 3 HIGH July 26, 1993
24732 K973910 22258 Genesis Diagnostics Anti-Gliadin Antibodies (AGA) ELISA (qualitative) 528 Anti-Gliadin Antibodies 3 HIGH April 16, 1999
24733 K964341 28513 IMMCO Diagnostics ImmuLisa Anti-Gliadin Ab (AGA) (qualitative) 528 Anti-Gliadin Antibodies 3 HIGH January 23, 1998
24734 K953495 58408 Scimedx GMB Antibody (computer calculations) 524 Anti-Glomerular Basement Membrane (GBM) Antibodies 3 HIGH May 17, 1996
24735 K962053 4687 ALPCO ORGenTec Anti-Jo-1 ELISA 438 Anti-Jo-1 3 HIGH March 28, 1997
24736 40024 MeDiCa AMA Test Kit 439 Anti-Mitochondrial Antibodies (AMTA) 3 HIGH July 26, 1993
24737 K955022 28439 INOVA Diagnostics QUANTA Lite MPO ELISA 505 Anti-Myeloperoxidase (MPO) Antibodies 3 HIGH April 5, 1996
24738 K980337 13541 Diamedix Immunosimplicity (Is) ANA Screen (manual) 441 Anti-Nuclear Antibodies (ANA) 3 HIGH December 18, 1998
24739 K950979 28396 Immuno Concepts HEp-2000 Colorzyme ANA-Ro Test System 441 Anti-Nuclear Antibodies (ANA) 3 HIGH June 9, 1995
24740 K944192 37098 Light Diagnostics ANA Test Kit with Rat Liver Substrate 441 Anti-Nuclear Antibodies (ANA) 3 HIGH March 10, 1995
24741 58256 Sanofi/Kallestad ANA Microplate EIA 441 Anti-Nuclear Antibodies (ANA) 3 HIGH July 26, 1993
24742 40008 MarDx Autoimmune IFA Screening Test System 442 Anti-Parietal Cell Antibodies 3 HIGH July 26, 1993
24743 K951206 16109 elias usa Varelisa Parietal Cell Abs (qualitative) 442 Anti-Parietal Cell Antibodies 3 HIGH April 28, 1995
24744 K942813 58329 Shield Diagnostics DIASTAT Anti-PR3 (cANCA) (semi-quantitative) 525 Anti-Proteinase-3 (PR-3) Antibodies 3 HIGH November 22, 1996
24745 K955481 61240 TheraTest Laboratories EL-ANA Profiles (anti-Sm, -RNP) 443 Anti-RNP (Ribonucleoprotein) 3 HIGH July 19, 1996
24746 K930141 16037 elias usa Synelisa Sm Abs/RNP-Sm Abs 443 Anti-RNP (Ribonucleoprotein) 3 HIGH November 22, 1993
24747 7239 BioWhittaker RheumELISA Plus Microwell Assay 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
24748 K955603 28450 Immuno Concepts RELISA SS-A/Ro - SS-B/LA 446 Anti-SS-A/Ro 3 HIGH August 9, 1996
24749 K935416 40183 Molecular Immunodiagnostics Ro EIA Test Kit 446 Anti-SS-A/Ro 3 HIGH June 10, 1994
24750 61018 TheraTest Laboratories EL-ANA Profiles Test 446 Anti-SS-A/Ro 3 HIGH July 26, 1993
24751 K924952 4504 Advanced Biological Products ELISA-DOXA Combi-6 (SS-A/Ro,SS-B/LA,Sm,RNP,Scl-70,Jo-1) 447 Anti-SS-B/La 3 HIGH November 22, 1993
24752 K931543 10255 Clark Laboratories ENA Combined Test Kit 447 Anti-SS-B/La 3 HIGH May 25, 1994
24753 K920384 28317 IMMCO Diagnostics Anti-ENA Antibody Test 447 Anti-SS-B/La 3 HIGH September 1, 1994
24754 K980639 52083 Quest International SeraQuest Anti-SSB (manual/qualitative) 447 Anti-SS-B/La 3 HIGH July 10, 1998
24756 K932206 16058 elias usa Synelisa ANA Profile (U1-snRNP,Sm,RNP-Sm,SS-A,SS-B,Scl-70,Centomer,Jo-1) 447 Anti-SS-B/La 3 HIGH June 10, 1994
24758 K935129 28330 Immuno Concepts RELISA ENA Antibody Screening Test 448 Anti-Scl-70 3 HIGH June 10, 1994
24759 40005 MarDx Anti-Skin Antibody Test System 449 Anti-Skin (Epidermal) Antibodies 3 HIGH July 26, 1993
24760 7239 BioWhittaker RheumELISA Plus Microwell Assay 450 Anti-Sm (Smith) 3 HIGH July 26, 1993
24761 K990625 10472 Cogent Diagnostics AUTOSTAT II Anti-Sm (IgG) ELISA 450 Anti-Sm (Smith) 3 HIGH July 9, 1999
24762 K930141 16037 elias usa Synelisa Sm Abs/RNP-Sm Abs 450 Anti-Sm (Smith) 3 HIGH November 22, 1993
24763 K971658 61290 The Binding Site Mouse Liver, Kidney, Stomach IFA 451 Anti-Smooth Muscle Antibodies (ASMA) 3 HIGH June 13, 1997
24768 K953066 7695 Bayer Serodia-ATG 453 Anti-Thyroglobulin Antibodies 3 HIGH October 6, 1995
24770 K923371 10207 Cogent Diagnostics AUTOSTAT Autoantibody Test Kit 455 Anti-Thyroid Microsomal Antibodies (AMA) 3 HIGH November 22, 1993
24771 K954256 7728 Biomerica Anti-Thyroid Peroxidase (Anti-TPO) ELISA 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH January 19, 1996
24772 K962451 25271 Hycor HY-TEC Thyroid Microsomal (TPO) Antibodies (manual) 527 Anti-Thyroid Peroxidase (TPO) Antibodies 3 HIGH June 13, 1997
24773 K961579 4677 American Bioproducts STA Compact Analyzer 456 Antithrombin III (ATIII) 4 HIGH November 1, 1996
24775 28077 Instrumentation Laboratory IL ACL 300 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
24776 40037 Medical Laboratory MLA Electra 1000 C 456 Antithrombin III (ATIII) 4 HIGH July 26, 1993
24785 K893884 25220 Horizon Apolipoprotein B (APO B) (manual) 457 Apolipoprotein B 2 HIGH April 28, 1995
24791 4275 Ames OPTIMATE 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
24792 7378 Beckman Manual Spectrophotometric Test Procedure 405 Aspartate Aminotransferase (AST) (SGOT) 2 HIGH July 26, 1993
24800 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 508 Aspartic Acid 2 HIGH November 10, 1994
24802 K945344 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
24805 K945344 46212 Olympus AU 5000 {CEDIA DAU} (manual curve) 701 Barbiturates 7 HIGH December 1, 1995
24834 58187 Seradyn Quick-Chem II 705 Bilirubin, Neonatal 2 HIGH July 26, 1993
24842 40126 Mallinckrodt Serometer 370 706 Bilirubin, Total 2 HIGH July 26, 1993
24846 58187 Seradyn Quick-Chem II 706 Bilirubin, Total 2 HIGH July 26, 1993
24847 58157 Stanbio Test Kit 706 Bilirubin, Total 2 HIGH July 26, 1993
24850 10031 Ciba Corning 158 708 Blood Gases 2 HIGH July 26, 1993
24855 4130 All Body Fluid Elements Microscopic ID Procedures 716 Body Fluid Microscopic Elements 4 HIGH July 26, 1993
24857 7328 BioWhittaker FIAX System 1001 C-Reactive Protein (CRP) 3 HIGH July 26, 1993
24879 40124 Medical Analysis Systems RefLab Test Kit 1005 Calcium, Total 2 HIGH July 26, 1993
24883 58186 Seragen Quick-Chem 1005 Calcium, Total 2 HIGH July 26, 1993
24888 K944562 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH December 1, 1995
24892 K944562 55484 Roche Diagnostics Hitachi 747 {CEDIA DAU} (manual curve) 1009 Cannabinoids (THC) 7 HIGH May 7, 1999
24893 61060 TOXI-LAB Cannabinoid (THC) Screen THC-PLUS 1009 Cannabinoids (THC) 7 HIGH July 26, 1993
24902 4036 Abbott Bichromatic ABA 200 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
24908 16010 Electronucleonics FLEXIGEM 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
24909 28158 Instrumentation Laboratory IL 508 1003 Carbon Dioxide, Total (CO2) 2 HIGH July 26, 1993
24916 K972167 8023 Bioanalytical Systems BAS Plasma Catecholamine Kit 1056 Catecholamines, Plasma 6 HIGH January 9, 1998
24920 K971470 28499 IMI MICRO21 {CSF Microscopic Cytoanalysis} (with cytospin) 1061 Cerebrospinal Fluid Microscopic Elements 4 HIGH December 5, 1997
24921 7375 Beckman Paragon Immunofixation Electrophoresis (IFE) Kit 1057 Cerebrospinal Fluid Protein Fractions 3 HIGH July 26, 1993
24922 4258 ADI Visuwell Chlamydia (direct Ag/visual) 1016 Chlamydia 8 HIGH July 26, 1993
24923 K935807 7914 Beckman ACCESS Immunoassay System 1016 Chlamydia 8 HIGH May 16, 1997
24924 K920302 22166 Gen-Probe Pace2 Probe Competition Assay (PCA) (direct Ag) 1016 Chlamydia 8 HIGH September 30, 1994
24926 58003 Sanofi/Kallestad Pathfinder Chlamydia Microplate (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH July 26, 1993
24927 K926090 58335 Syva MicroTrak II Chlamydia EIA Blocking Assay (direct Ag/spectrophotometric) 1016 Chlamydia 8 HIGH October 28, 1994
24928 4035 Abbott Bichromatic ABA 100 1018 Chloride 2 HIGH July 26, 1993
24941 K882938 61377 TECO Diagnostics TC 84 1018 Chloride 2 HIGH November 19, 1998
24942 61046 Technicon SMAC 3 1018 Chloride 2 HIGH July 26, 1993
24949 16010 Electronucleonics FLEXIGEM 1020 Cholesterol 2 HIGH July 26, 1993
24953 40124 Medical Analysis Systems RefLab Test Kit 1020 Cholesterol 2 HIGH July 26, 1993
24963 55075 Reagents Applications RAICHEM Test Kit (manual) 1021 Cholinesterase 2 HIGH July 26, 1993
24968 K931956 25156 Helena Laboratories Cascade M 1044 Coagulation Factors 4 HIGH November 22, 1993
24969 28073 Instrumentation Laboratory IL ACL 100 1044 Coagulation Factors 4 HIGH July 26, 1993
24970 K934584 40180 MeDiTech Chromogenic Factor VIII:C Assay Kit 1044 Coagulation Factors 4 HIGH June 10, 1994
24971 46123 Ortho Koagulab 32-S 1044 Coagulation Factors 4 HIGH July 26, 1993
24975 K941310 7721 Boehringer Mannheim Hitachi 911 {CEDIA DAU} (manual curve) 1023 Cocaine Metabolites 7 HIGH December 1, 1995
24976 13111 Diagnostic Products Corp. Milenia 1023 Cocaine Metabolites 7 HIGH July 26, 1993
24980 K934775 58379 STC Technologies Cocaine M-Plate EIA {Sudormed Patch} 1023 Cocaine Metabolites 7 HIGH September 8, 1995
24984 K951968 34010 Kent Radial Immunodiffusion Test 1064 Complement C1q 3 HIGH July 28, 1995
24986 34003 Kallestad Quantiplate RID 1029 Complement C3 3 HIGH July 26, 1993
24998 4146 Amersham Amerlex 1032 Cortisol 6 HIGH July 26, 1993
25003 K936145 37074 Light Diagnostics MAb Coxsackie B1 Virus (including culture) 1099 Coxsackie B1 Virus 10 HIGH September 15, 1995
25004 4036 Abbott Bichromatic ABA 200 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
25016 58161 Seradyn CK-UV Determination 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
25018 61045 Technicon SMAC 2 1034 Creatine Kinase (CK) 2 HIGH July 26, 1993
25019 25102 Helena Laboratories REP CK Stat Isoenzyme Procedure 1052 Creatine Kinase Isoenzymes (CK Isoenzymes) 2 HIGH July 26, 1993
25020 4036 Abbott Bichromatic ABA 200 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
25027 K931050 25139 Helena Laboratories Cardio REP CK Isoenzyme Procedure 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH November 22, 1993
25028 28171 International Immunoassay Labs CARDIA-CK 1002 Creatine Kinase MB Fraction (CKMB) 2 HIGH July 26, 1993
25038 K880843 25206 Horizon Creatinine (manual) 1035 Creatinine 2 HIGH April 28, 1995
25039 28183 Instrumentation Laboratory Multistat III 1035 Creatinine 2 HIGH July 26, 1993
25045 58195 SmithKline ESKALAB-CCS 1035 Creatinine 2 HIGH July 26, 1993
25048 28199 Incstar CYCLO-Trac SP 1037 Cyclosporine 7 HIGH July 26, 1993
25049 46051 Ortho CMV Identification Reagent (including cell culture) 1038 Cytomegalovirus 10 HIGH July 26, 1993
25052 28018 Immucor Capture CMV 1039 Cytomegalovirus Antibodies 3 HIGH July 26, 1993
25054 K924096 79040 Zeus Scientific CMV ELISA (simultaneous IgM & IgG) 1039 Cytomegalovirus Antibodies 3 HIGH November 22, 1993
25056 22029 Gamma STS-M Automated Blood Grouping Instrument 1301 D(Rho) Type 5 HIGH July 26, 1993
25062 10060 Clinical Assays GammaCoat 1303 Digitoxin 7 HIGH July 26, 1993
25065 4061 Abbott RIA Bead 1304 Digoxin 7 HIGH July 26, 1993
25068 7141 Bio-Rad Quantimune 1304 Digoxin 7 HIGH July 26, 1993
25080 K940473 37088 Light Diagnostics MAb Enterovirus 71 (including culture) 1626 Enterovirus 71 10 HIGH September 15, 1995
25081 7285 Baxter Bartels PRIMA Epstein Barr Virus IgG EIA 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
25082 K981812 13556 Diamedix Immunosimplicity (Is)-EBV-VCA IgG (manual) 1603 Epstein-Barr virus Antibodies 3 HIGH May 24, 1999
25083 K921628 28266 Incstar Clin-ELISA EBV EA(D) IgG 1603 Epstein-Barr virus Antibodies 3 HIGH November 22, 1993
25084 58174 Sigma Diagnostics SIA Epstein-Barr VCA IgM 1603 Epstein-Barr virus Antibodies 3 HIGH July 26, 1993
25085 13116 Difco Bacto E. coli H H7 (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
25086 13127 Difco Bacto E. coli OK (including culture) 1604 Escherichia coli 8 HIGH July 26, 1993
25087 4148 Amersham Amerlite 1605 Estradiol 6 HIGH July 26, 1993
25091 E990022 34095 KMI Diagnostics Estriol RIA 1606 Estriol, Total 6 HIGH March 26, 1999
25104 28183 Instrumentation Laboratory Multistat III 1920 Factor X 4 HIGH July 26, 1993
25111 13179 Diagnostic Systems Active Ferritin IEMA Kit 1902 Ferritin 2 HIGH July 26, 1993
25118 K925988 7517 Behring Multifibrin (manual) 1905 Fibrinogen 4 HIGH November 22, 1993
25132 K894011 4696 Astoria-Pacific API 300 SPOTCHECK System 2223 Galactose, Total 2 HIGH April 18, 1997
25135 13216 DMA Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
25136 13210 Diagnostic Chemicals Ltd. Assay Kit (manual) 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
25137 16010 Electronucleonics FLEXIGEM 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
25142 61044 TRACE Scientific Test Kit 2201 Gamma Glutamyl Transferase (GGT) 2 HIGH July 26, 1993
25144 10061 Clinical Assays GammaDab 2205 Gastrin 6 HIGH July 26, 1993
25150 58082 Syva Emit Test Kit 2202 Gentamicin 7 HIGH July 26, 1993
25151 4099 Alexon-Trend ProSpecT Giardia Microtiter (direct Ag/visual) 2222 Giardia lamblia 11 HIGH February 3, 1995
25152 58183 Seradyn Color Vue - Giardia (direct Ag/spectrophotometric) 2222 Giardia lamblia 11 HIGH February 3, 1995
25153 13031 Diagnostic Products Corp. Double Antibody 2206 Glucagon 6 HIGH July 26, 1993
25161 K914159 25218 Horizon Glucose (Oxidase) (manual) 2203 Glucose 2 HIGH April 28, 1995
25165 40126 Mallinckrodt Serometer 370 2203 Glucose 2 HIGH July 26, 1993
25169 58187 Seradyn Quick-Chem II 2203 Glucose 2 HIGH July 26, 1993
25171 61014 Technicon SMA 12/60 2203 Glucose 2 HIGH July 26, 1993
25183 46007 Organon NML IRMA Test Kit 2501 HCG, Serum, Qualitative 6 HIGH July 26, 1993
25192 7071 Beckman Synchron CX 4 2550 HDL Cholesterol 2 HIGH July 26, 1993
25195 K950958 8076 Beckman Synchron LX System 2550 HDL Cholesterol 2 HIGH April 10, 1998
25196 7162 Boehringer Mannheim Hitachi 705 2550 HDL Cholesterol 2 HIGH July 26, 1993
25199 7166 Boehringer Mannheim Hitachi 747 2550 HDL Cholesterol 2 HIGH July 26, 1993
25206 13213 DataChem DC-100 2550 HDL Cholesterol 2 HIGH July 26, 1993
25209 28083 Instrumentation Laboratory IL Monarch Plus 2550 HDL Cholesterol 2 HIGH July 26, 1993
25216 K961274 46229 Olympus AU 600 2550 HDL Cholesterol 2 HIGH February 14, 1997
25217 46002 Olympus Demand 2550 HDL Cholesterol 2 HIGH July 26, 1993
25223 55401 Roche Diagnostics Hitachi 717 2550 HDL Cholesterol 2 HIGH May 7, 1999
25227 61011 Technicon RA 2000 2550 HDL Cholesterol 2 HIGH July 26, 1993
25230 10010 Cambridge Biotech Recombigen (env. & gag) HIV-1 EIA 2506 HIV Antibodies 3 HIGH July 26, 1993
25231 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 2510 Haemophilus influenzae, type b 8 HIGH June 7, 1996
25235 34010 Kent Radial Immunodiffusion Test 2511 Haptoglobin 2 HIGH July 26, 1993
25242 13279 DMA H5-M 2514 Hematocrit 4 HIGH September 1, 1994
25261 13250 Data Medical Associates Hemoglobin Determination 2515 Hemoglobin 4 HIGH July 26, 1993
25267 58226 Sigma Diagnostics Plasma Hemoglobin 2515 Hemoglobin 4 HIGH July 26, 1993
25271 7373 Beckman Paragon Hemoglobin (Hb) Electrophoresis Kit 2544 Hemoglobin Fractions 2 HIGH July 26, 1993
25273 K955278 7824 Behring Coagulation Timer (BCT) 2518 Heparin 4 HIGH November 15, 1996
25274 28078 Instrumentation Laboratory IL ACL 3000 2518 Heparin 4 HIGH July 26, 1993
25275 K931992 67075 Vitek HEMOLAB 2518 Heparin 4 HIGH January 6, 1995
25276 58057 Sorin Biomedica CORE-IgMK IRMA 2521 Hepatitis B Core Antibody 3 HIGH July 26, 1993
25277 4026 Abbott AUSAB Quantitation Panel 2523 Hepatitis B Surface Antibody 3 HIGH July 26, 1993
25279 4051 Abbott HBe RIA 2525 Hepatitis Be Antibody 3 HIGH July 26, 1993
25280 4334 Abbott COMMANDER System 2527 Hepatitis C Virus Antibody 3 HIGH July 26, 1993
25281 13036 Diagnostic Products Corp. PathoDx Herpes Typing (direct Ag) 2529 Herpes simplex 10 HIGH July 26, 1993
25282 46105 Ortho HSV Antigen ELISA Test (including cell culture/spectrophotometric) 2529 Herpes simplex 10 HIGH July 26, 1993
25283 4161 Amico Amizyme HSV Ab Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
25284 7286 Baxter Bartels PRIMA HSV 2 IgM EIA 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
25285 K771063 22083 Gull Laboratories HSV IgG IFA Test 2530 Herpes simplex I and/or II Antibodies 3 HIGH July 26, 1993
25287 K943978 70171 Waters Pico-Tag Amino Acid Analysis System 2563 Histidine 2 HIGH May 26, 1995
25288 28205 Incstar hGH 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
25289 40117 Medix Biotech EIA Test Kit 2547 Human Growth Hormone (GH) 6 HIGH July 26, 1993
25290 4275 Ames OPTIMATE 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
25293 28183 Instrumentation Laboratory Multistat III 2803 Immunoglobulins IgA 3 HIGH July 26, 1993
25298 25022 Hybritech Tandem-E 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
25299 K941278 25174 Hycor HY-TEC Total IgE - EIA (manual) 2805 Immunoglobulins IgE 3 HIGH March 17, 1995
25300 49046 Pharmacia CAP System IgE FEIA 2805 Immunoglobulins IgE 3 HIGH July 26, 1993
25306 7383 Beckman Auto ICS 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
25309 25005 Helena Laboratories Quiplate System for RID 2808 Immunoglobulins IgM 3 HIGH July 26, 1993
25315 13112 Diagnostic Products Corp. Solid Phase 2817 Intrinsic Factor Blocking Antibody (IFbAb) 3 HIGH July 26, 1993
25320 34050 Kenlor Industries Test Kit 2814 Iron 2 HIGH July 26, 1993
25326 58157 Stanbio Test Kit 2814 Iron 2 HIGH July 26, 1993
25327 K950958 7762 Beckman Synchron CX 4 DELTA 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH April 19, 1996
25328 K941050 13423 Dade aca Star 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH July 12, 1996
25329 34056 Kodak Ektachem 550 XRC 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH September 1, 1994
25330 K953239 55560 Roche Diagnostics Hitachi 917 2815 Iron Binding Capacity (post saturation/separation) 2 HIGH May 7, 1999
25331 K964063 4752 Abbott Bichromatic ABA 100 {RDI LDL Precipitating Reagent} 3748 LDL Cholesterol 2 HIGH December 5, 1997
25334 K964063 16162 EM Diagnostic Systems EPOS {RDI Precipitating Reagent} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 5, 1997
25336 K943150 34091 Kodak Ektachem 700 {Genzyme immunoseparation tube} (cholesterol slide) 3748 LDL Cholesterol 2 HIGH April 21, 1995
25338 K964064 46283 Ortho-Clinical Diagnostics Vitros {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH February 20, 1998
25345 K964064 61336 Technicon RA 1000 {RDI Unitized LipiDirect Magnetic LDL} (manual calculations) 3748 LDL Cholesterol 2 HIGH December 19, 1997
25355 58157 Stanbio Test Kit 3701 Lactate Dehydrogenase (LDH) 2 HIGH July 26, 1993
25357 4267 Abbott Bichromatic ABA 50 3702 Lactate Dehydrogenase Heart Fraction (LDH-1) 2 HIGH July 26, 1993
25361 4035 Abbott Bichromatic ABA 100 3704 Lactic Acid (Lactate) 2 HIGH July 26, 1993
25369 7381 Beckman ICS 3705 Lambda Light Chains 3 HIGH July 26, 1993
25371 K991074 28574 INTRACEL Bartels Legionella Urinary Antigen ELISA (direct Ag/visual) 3778 Legionella pneumophilia Serogroup 1 Antigen 3 HIGH January 27, 2000
25373 28184 Instrumentation Laboratory Multistat III Plus 3710 Lidocaine 7 HIGH July 26, 1993
25380 40123 Medical Analysis Systems Test Kit 3711 Lipase 2 HIGH July 26, 1993
25384 25071 Helena Laboratories HDL Cholesterol Electrophoresis 3720 Lipoprotein Fractions 2 HIGH July 26, 1993
25390 K932463 7522 Biopool Bioclot LA (manual) 3728 Lupus Anticoagulants 4 HIGH May 20, 1994
25393 K930306 55121 Roche Diagnostics Cobas Core LH EIA (manual) 3713 Luteinizing Hormone (LH) 6 HIGH November 22, 1993
25397 79017 Zeus Scientific Lyme IgM ELISA 3714 Lyme Disease Antibodies (Borrelia burgdorferi Abs) 3 HIGH July 26, 1993
25398 K875047 10330 Coulter EPICS XL 3763 Lymphocytes, CD2 3 HIGH May 10, 1996
25399 K926124 10246 Coulter Epics Flow Cytometer 3765 Lymphocytes, CD3/CD19 3 HIGH November 22, 1993
25400 K946055 7637 Becton Dickinson FACSort 3769 Lymphocytes, CD3/CD4/CD45 3 HIGH February 23, 1996
25401 K933486 7601 Becton Dickinson FACSCount 3767 Lymphocytes, CD3/CD8 3 HIGH December 23, 1994
25402 K895917 10246 Coulter Epics Flow Cytometer 3774 Lymphocytes, CD4/CD8 3 HIGH September 1, 1994
25404 4035 Abbott Bichromatic ABA 100 4002 Magnesium 2 HIGH July 26, 1993
25405 4144 American Monitor Parallel 4002 Magnesium 2 HIGH July 26, 1993
25415 58157 Stanbio Test Kit 4002 Magnesium 2 HIGH July 26, 1993
25420 13030 Diagnostic Products Corp. Coat-A-Count 4003 Methadone 7 HIGH July 26, 1993
25425 K954227 55567 Roche Diagnostics Hitachi 917 {CEDIA DAU} (manual curve) 4003 Methadone 7 HIGH May 7, 1999
25426 58103 Sigma Diagnostics SIA Methamphetamine/Amphetamine 4036 Methamphetamine/Amphetamine 7 HIGH December 1, 1995
25430 K972989 58503 STC Technologies Methamphetamine Micro-Plate EIA {EpiScreen Oral Fluid Specimens} 4004 Methamphetamines 7 HIGH April 24, 1998
25442 K961864 61280 TECO Diagnostics CSF/Urine Total Protein (manual) 4026 Microprotein, CSF 2 HIGH April 4, 1997
25445 K921412 58230 Sterling Diagnostics Test Kit 4027 Microprotein, Urine 2 HIGH November 22, 1993
25446 K884605 10331 Coulter EPICS XL-MCL 4041 Monocytes, CD14 (Mo2) 3 HIGH May 10, 1996
25448 4123 All Manual Nucleic Acid Analysis Test Systems & Procedures (isotopic) 4024 Mycobacteria 9 HIGH July 26, 1993
25449 7338 BioWhittaker MYCOPLASMA STAT 4016 Mycoplasma pneumoniae Antibodies 3 HIGH July 26, 1993
25459 4045 Abbott Gonozyme (direct Ag/spectrophotometric) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
25460 K920301 22144 Gen-Probe Pace2 (including culture) 4302 Neisseria gonorrhoeae 8 HIGH July 26, 1993
25462 K952791 7726 Becton Dickinson Directigen Meningitis Combo (including culture) 4311 Neisseria meningitidis, group W135 8 HIGH June 7, 1996
25464 K952791 7727 Becton Dickinson Directigen Neisseria Meningitis (including culture) 4312 Neisseria meningitidis, group Y 8 HIGH June 7, 1996
25467 K945343 7723 Beckman Synchron CX 5 {CEDIA DAU} (manual curve) 4601 Opiates 7 HIGH December 1, 1995
25472 28183 Instrumentation Laboratory Multistat III 4601 Opiates 7 HIGH July 26, 1993
25476 K924446 58298 STC Technologies Opiates EIA Plate Kit 4601 Opiates 7 HIGH November 22, 1993
25478 K925093 7553 Beckman System 6300 Series Amino Acid Analyzer 4606 Ornithine 2 HIGH November 10, 1994
25481 4082 Abbott VP 4605 Oxalate 2 HIGH July 26, 1993
25482 16004 Electronucleonics Gem-Profiler 4605 Oxalate 2 HIGH July 26, 1993
25483 16007 Electronucleonics Gemstar II 4605 Oxalate 2 HIGH July 26, 1993
25499 K933575 58315 Symex ViraSTAT Anti-Parainfluenza MAbs 4960 Parainfluenza 2 10 HIGH January 6, 1995
25500 K970483 58446 SeaLite Sciences AquaLite Intact PTH 4924 Parathyroid Hormone - Intact 6 HIGH May 2, 1997
25503 K946059 7720 Boehringer Mannheim Hitachi 747 {CEDIA DAU} (manual curve) 4901 Phencyclidine (PCP) 7 HIGH December 1, 1995
25520 K961515 58425 Shield Diagnostics Quantase Phenylalanine 4942 Phenylalanine 2 HIGH November 22, 1996
25527 58051 Sigma Diagnostics Test Kit 4943 Phosphohexose Isomerase 2 HIGH July 26, 1993
25543 K974711 28539 Instrumentation Laboratory IL ACL 200 {Chromogenix Coamatic Plasminogen} 4907 Plasminogen 4 HIGH December 8, 1998
25544 K961991 28487 Instrumentation Laboratory IL ACL 7000 4907 Plasminogen 4 HIGH September 19, 1997
25545 4361 American Diagnostica Spectrolyse/Fibrin 4936 Plasminogen Activator Inhibitor (PAI) 4 HIGH July 26, 1993
25559 K940018 37080 Light Diagnostics MAb Poliovirus 1 (including culture) 4966 Poliovirus 1 10 HIGH September 15, 1995
25576 55007 Radiometer Flame Photometer 4910 Potassium 2 HIGH July 26, 1993
25578 58157 Stanbio Test Kit 4910 Potassium 2 HIGH July 26, 1993
25580 61045 Technicon SMAC 2 4910 Potassium 2 HIGH July 26, 1993
25592 7138 Bio-Rad CoTube 4914 Progesterone 6 HIGH July 26, 1993
25597 13030 Diagnostic Products Corp. Coat-A-Count 4915 Prolactin 6 HIGH July 26, 1993
25598 25022 Hybritech Tandem-E 4915 Prolactin 6 HIGH July 26, 1993
25607 28095 ITC HEMOCHRON 401 4945 Protamine Response Test (PRT) 4 HIGH July 26, 1993
25608 K922201 10252 Chromogenix COAMATE Protein C (manual) 4929 Protein C 4 HIGH November 22, 1993
25609 K980875 28395 Instrumentation Laboratory IL ACL Futura System 4929 Protein C 4 HIGH December 8, 1998
25610 K922201 55100 Roche Diagnostics Cobas Bio 4929 Protein C 4 HIGH November 22, 1993
25611 K930327 28074 Instrumentation Laboratory IL ACL 1000 4930 Protein S 4 HIGH November 22, 1993
25617 13216 DMA Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
25619 28158 Instrumentation Laboratory IL 508 4921 Protein, Total 2 HIGH July 26, 1993
25626 58157 Stanbio Test Kit 4921 Protein, Total 2 HIGH July 26, 1993
25637 28184 Instrumentation Laboratory Multistat III Plus 4941 Pyruvate 2 HIGH July 26, 1993
25642 4115 All Immunohematology Absorption/Elution Procedures-Ag confirmation 5501 RBC antigen type other than A or B 5 HIGH July 26, 1993
25650 13283 DMA H10 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
25651 13278 DMA H3-Hgb 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
25653 40169 Mallinckrodt S-610 5502 Red Blood Cell Count (Erythrocyte Count) (RBC) 4 HIGH September 1, 1994
25658 K912842 22162 Gull Laboratories RSV-MAb Test (direct Ag) 5503 Respiratory syncytial virus 10 HIGH July 26, 1993
25661 13245 Diamedix RF Microassay 5508 Rheumatoid Factor (RF) 3 HIGH July 26, 1993
25665 K912666 13330 DAKO ELISA Rotavirus Kit (direct Ag/visual) 5509 Rotavirus 10 HIGH March 3, 1995
25666 4066 Abbott Rubazyme-M 5510 Rubella Antibodies 3 HIGH July 26, 1993
25681 4355 All Manual Semen Analyses (count and morphology) 5822 Semen 4 HIGH July 26, 1993
25682 7283 Becton Dickinson BBL Shigella Grouping (including culture) 5804 Shigella 8 HIGH July 26, 1993
25704 58051 Sigma Diagnostics Test Kit 5823 Sorbital Dehydrogenase (SDH) 2 HIGH July 26, 1993
25705 4205 Analytab API Staphase III (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
25706 40036 Medical Diag. Technologies Staph Latex (including culture) 5807 Staphylococcus 8 HIGH July 26, 1993
25707 7261 Becton Dickinson Directigen Meningitis Indiv.Kit (blood culture supernatant) 5808 Streptococcus pneumoniae 8 HIGH July 26, 1993
25708 7083 Becton Dickinson BBL Strep Grouping (including culture) 5810 Streptococcus, group A 8 HIGH July 26, 1993
25713 7083 Becton Dickinson BBL Strep Grouping (including culture) 5811 Streptococcus, group B 8 HIGH July 26, 1993
25715 E990006 61390 The Binding Site Streptococcus Grouping Reagents 5814 Streptococcus, group F 8 HIGH March 12, 1999
25716 4071 Abbott TDX 5833 Surfactant/Albumin Ratio 2 HIGH September 1, 1994
25720 E990032 4863 Alfa Scientific Designs Microwell Testosterone EIA 6102 Testosterone 6 HIGH July 23, 1999
25723 4156 Ames TDA 6104 Theophylline 7 HIGH July 26, 1993
25728 28183 Instrumentation Laboratory Multistat III 6104 Theophylline 7 HIGH July 26, 1993
25737 K962216 7840 Biomerica TSH Microwell ELISA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH January 31, 1997
25739 43008 Nichols Institute Allegro RIA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH July 26, 1993
25740 K923532 58308 STC Technologies TSH Micro-Plate EIA 6106 Thyroid Stimulating Hormone (TSH) 6 HIGH November 22, 1993
25744 40117 Medix Biotech EIA Test Kit 6108 Thyroid Stimulating Hormone - high sens. (TSH-HS) 6 HIGH July 26, 1993
25746 K982298 8221 Biotecx Laboratories OptiCoat T4 EIA 6109 Thyroxine (T4) 6 HIGH September 16, 1999
25751 40111 Micromedic Systems Concept 4 Plus 6109 Thyroxine (T4) 6 HIGH July 26, 1993
25754 43044 Nichols Institute RIA Kit 6110 Thyroxine Binding Globulin (TBG) 6 HIGH July 26, 1993
25757 K981243 8118 Biostride Free T4 EIA 6111 Thyroxine, Free (FT4) 6 HIGH July 31, 1998
25759 K883123 31016 Johnson & Johnson CDL Amerlite Analyzer 6111 Thyroxine, Free (FT4) 6 HIGH August 18, 1995
25761 67081 Ventana AEC Detection Kit 6163 Tissue (Cell) Antigens 3 HIGH September 1, 1994
25764 13030 Diagnostic Products Corp. Coat-A-Count 6112 Tobramycin 7 HIGH July 26, 1993
25766 58082 Syva Emit Test Kit 6112 Tobramycin 7 HIGH July 26, 1993
25771 13052 Diagnostic Technology Toxo/IgM Check 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
25773 28216 Incstar Clin-ELISA Toxoplasma gondii IgM 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
25774 K960092 52043 Quest International SeraQuest Toxo IgG (manual/semi-quantitative) 6113 Toxoplasma gondii Antibodies 3 HIGH December 6, 1996
25775 70089 Wampole TPM-TEST 6113 Toxoplasma gondii Antibodies 3 HIGH July 26, 1993
25777 7119 Behring Nor-partigen Kit 6114 Transferrin 2 HIGH July 26, 1993
25787 79007 Zeus Scientific FTA-ABS 6115 Treponema pallidum Antibodies (includes Reagin) 3 HIGH July 26, 1993
25789 7279 Bio-Rad HPLC 6117 Tricyclic Antidepressants 7 HIGH July 26, 1993
25800 40118 Meditech Diagnostic System Test Kit 6118 Triglyceride 2 HIGH July 26, 1993
25809 K960550 13413 Diagnostic Systems DSL 3100 ACTIVE T3 Coated-Tube RIA 6119 Triiodothyronine (T3) 6 HIGH April 12, 1996
25810 37029 Leeco Diagnostics RIA Test Kit 6119 Triiodothyronine (T3) 6 HIGH July 26, 1993
25820 4147 Amersham Amerlex-M 6121 Triiodothyronine, Free (FT3) 6 HIGH July 26, 1993
25825 4114 All Immunohematology Unexpected RBC Antibody ID Procedures 6402 Unexpected RBC antibody - identification 5 HIGH July 26, 1993
25833 28183 Instrumentation Laboratory Multistat III 6403 Urea (BUN) 2 HIGH July 26, 1993
25840 58229 Sterling Diagnostics Analyzer 2000 6403 Urea (BUN) 2 HIGH July 26, 1993
25844 7378 Beckman Manual Spectrophotometric Test Procedure 6404 Uric Acid 2 HIGH July 26, 1993
25849 28184 Instrumentation Laboratory Multistat III Plus 6404 Uric Acid 2 HIGH July 26, 1993
25881 28183 Instrumentation Laboratory Multistat III 6409 Urokinase 2 HIGH July 26, 1993
25891 K961012 79050 Zeus Scientific Varicella-Zoster IgG ELISA 6704 Varicella-Zoster Virus Antibodies 3 HIGH November 8, 1996
25893 10063 Clinical Assays Solid Phase 6707 Vitamin B12 2 HIGH July 26, 1993
25894 13028 Diagnostic Products Corp. Charcoal Boil 6707 Vitamin B12 2 HIGH July 26, 1993
25897 4302 All Manual White Blood Cell Count Procedures 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
25900 10108 Coulter F 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
25903 10129 Coulter ZF5 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH July 26, 1993
25907 40173 Mallinckrodt S-670 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
25911 61123 Texas International Laboratories H5-M 7002 White Blood Cell Count (Leukocyte Count) (WBC) 4 HIGH September 1, 1994
25917 4195 Analytab API 20C Yeast Identification Kit (including culture) 7601 Yeast 12 HIGH July 26, 1993
25918 28104 Immuno-Mycologics LA-Candida (direct Ag) 7603 Yeast, Candida only 12 HIGH July 26, 1993
25919 22136 Gen-Probe AccuProbe - Cryptococcus (including culture) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
25925 40092 Meridian Diagnostics Premier C difficile Toxin A (direct Ag/spectrophotometric) 1022 Clostridium difficile 8 HIGH July 26, 1993
25926 40093 Meridian Diagnostics Premier C. difficile Toxin A (direct Ag/visual) 1022 Clostridium difficile 8 HIGH July 26, 1993
25927 K955360 28461 Incstar CMV IgG 'fast' ELISA 1039 Cytomegalovirus Antibodies 3 HIGH November 8, 1996
25928 K981734 13595 Denka Seiken VTEC-RPLA 'SEIKEN' (including culture) 1604 Escherichia coli 8 HIGH January 7, 2000
25929 K950167 40204 Meridian Diagnostics Premier EHEC (visual) 1604 Escherichia coli 8 HIGH April 28, 1995
25932 K945558 40199 Meridian Diagnostics Premier H. pylori EIA (spectrophotometric) 2513 Helicobacter pylori Antibodies 3 HIGH March 10, 1995
25933 K945558 40198 Meridian Diagnostics Premier H. pylori EIA (visual) 2513 Helicobacter pylori Antibodies 3 HIGH March 10, 1995
25934 40105 Meridian Diagnostics Premier Helicobacter pylori HM-CAP 2513 Helicobacter pylori Antibodies 3 HIGH July 26, 1993
25935 K955362 28458 Incstar HSV I/II IgG 'fast' ELISA 2530 Herpes simplex I and/or II Antibodies 3 HIGH November 8, 1996
25937 K960358 28472 Incstar Rubella IgG 'fast' ELISA Kit 5510 Rubella Antibodies 3 HIGH January 24, 1997
25938 K963297 28468 Incstar Toxoplasma IgG 'fast' ELISA Kit 6113 Toxoplasma gondii Antibodies 3 HIGH January 24, 1997
25939 40057 Meridian Diagnostics Cryptococcal LA System (direct Ag) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
25940 40072 Meridian Diagnostics Premier Cryptococcal Ag (direct Ag/spectrophotometric) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
25941 40071 Meridian Diagnostics Premier Cryptococcal Ag (direct Ag/visual) 7604 Yeast, Cryptococcus only 12 HIGH July 26, 1993
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