| WIELISA ANCA SCREENING KIT TEST SYSTEM (K981748) | Wieslab AB | 1998-07-22 |
| WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM (K981750) | Wieslab AB | 1998-07-22 |
| BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT (K981030) | The Binding Site, Ltd. | 1998-07-20 |
| BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT (K981029) | The Binding Site, Ltd. | 1998-07-20 |
| ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K981698) | Chiron Corp. | 1998-07-10 |
| ACS:CENTAUR AFP (K981592) | Chiron Diagnostics Corp. | 1998-07-07 |
| UNICAP THYROID PEROXIDASE IGG (K981930) | Pharmacia & Upjohn Co. | 1998-07-07 |
| UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY (K981559) | Pharmacia & Upjohn Co. | 1998-07-07 |
| QUANTECH MYOGLOBIN ASSAY (K981536) | Hellen Professional Services | 1998-06-29 |
| ELECSYS CEA ON THE ELECSYS 1010 (K980887) | Boehringer Mannheim Corp. | 1998-06-29 |
| QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT (K981330) | Inova Diagnostics, Inc. | 1998-06-19 |
| QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT (K981328) | Inova Diagnostics, Inc. | 1998-06-19 |
| COLOR-SLIDE RF (K981496) | Seradyn, Inc. | 1998-06-15 |
| SERAQUEST ANTI-SM (K980540) | Quest Intl., Inc. | 1998-06-15 |
| SERAQUEST ANTI-SSB (K980639) | Quest Intl., Inc. | 1998-06-15 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K981638) | Beckman Coulter, Inc. | 1998-06-12 |
| QUANTA LITE RIBOSOME P ELISA (K981237) | Inova Diagnostics, Inc. | 1998-06-05 |
| ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM (K981021) | Zeus Scientific, Inc. | 1998-06-02 |
| ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM (K981014) | Zeus Scientific, Inc. | 1998-06-02 |
| AIA-PACK MYOGLOBIN ASSAY (K981012) | Tosoh Medics, Inc. | 1998-05-28 |
| ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM (K981020) | Zeus Scientific, Inc. | 1998-05-18 |
| SERAQUEST ANTI-SSA (K980810) | Quest Intl., Inc. | 1998-05-12 |
| DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (K980337) | Helix Diagnostics, Inc. | 1998-05-12 |
| SERAQUEST ANTI-SM/RNP (K980811) | Quest Intl., Inc. | 1998-05-12 |
| IMMULITE ANTI-TG AB (K980206) | Diagnostic Products Corp. | 1998-05-01 |
| ELECSYS AFP (K981282) | Roche Diagnostics GmbH | 1998-05-01 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (K981354) | Beckman Instruments, Inc. | 1998-05-01 |
| STRATUS CS MYOGLOBIN (MYO) TESTPAK (K981102) | Dade Behring, Inc. | 1998-04-27 |
| SERAQUEST ANTI-DSDNA (K980391) | Quest Intl., Inc. | 1998-04-24 |
| THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K980376) | Bayer Corp. | 1998-04-23 |
| DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM (K980759) | Diamedix Corp. | 1998-04-23 |
| IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT (K980855) | Dpc Cirrus | 1998-04-21 |
| IMMULITE 2000 3RD GENERATION PSA (K974842) | Diagnostic Products Corp. | 1998-04-21 |
| BARD BTA TRAK TEST (K971402) | Bard Diagnostic Sciences,Inc. | 1998-04-15 |
| ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY (K980716) | Nichols Institute Diagnostics | 1998-04-03 |
| NOVA LITE ENDOMYSIAL (K980312) | Inova Diagnostics, Inc. | 1998-04-02 |
| ELECSYS CA 125II ON THE ELECSYS 1010 (K980240) | Boehringer Mannheim Corp. | 1998-03-25 |
| QUANTA LITE B2 GPI SCREEN (K980230) | Inova Diagnostics, Inc. | 1998-03-24 |
| ELECSYS CA 125 II (K972162) | Boehringer Mannheim Corp. | 1998-03-18 |
| IMMUSTRIP HAMA IGG (K972873) | Immunomedics, Inc. | 1998-03-17 |
| DIAMEDIX IS-RF TEST SYSTEM (K974889) | Diamedix Corp. | 1998-03-06 |
| ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) (K980190) | Chiron Corp. | 1998-03-06 |
| HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591) | Morax | 1998-03-04 |
| IS-DSDNA TEST SYSTEM (K974694) | Diamedix Corp. | 1998-03-03 |
| HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K972145) | Immuno Concepts, Inc. | 1998-02-24 |
| ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (K974816) | Beckman Instruments, Inc. | 1998-02-20 |
| RAPET CRP (K974429) | Stanbio Laboratory | 1998-02-18 |
| AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 (K974505) | Alfa Biotech (Uk) , Ltd. | 1998-02-17 |
| WIELISA MPO ANCA TEST SYSTEM (K974166) | Wieslab AB | 1998-02-17 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (K974564) | Beckman Instruments, Inc. | 1998-02-17 |
| WIELISA ANTI-GBM TEST SYSTEM (K974169) | Wieslab AB | 1998-02-17 |
| ORGENTEC ANTI-MPO (P-ANCA) ELISA (K974701) | American Laboratory Products Co., Ltd. | 1998-02-17 |
| WIELISA PR-3 ANCA TEST SYSTEM (K974167) | Wieslab AB | 1998-02-17 |
| RAPET RF (K974370) | Stanbio Laboratory | 1998-02-17 |
| ORGENTEC ANTI-PR3 (C-ANCA) ELISA (K974702) | American Laboratory Products Co., Ltd. | 1998-02-17 |
| ALLERGEN IMMUNOCAP F256,F245,F207,F202 (K974580) | Pharmacia & Upjohn Co. | 1998-02-09 |
| UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (K973692) | United Biotech, Inc. | 1998-02-09 |
| IMMUNO CONCEPTS ANCA TEST SYSTEM (K974463) | Immuno Concepts, Inc. | 1998-02-09 |
| ALLERGAN IMMUNO CAP M4, M8, K70 (K974350) | Pharmacia, Inc. | 1998-02-09 |
| IMMUNO CONCEPTS ANCA TEST SYSTEMS (K974478) | Immuno Concepts, Inc. | 1998-02-09 |
| TINA-QUANT PREALBUMIN (K972638) | Boehringer Mannheim Corp. | 1998-01-09 |
| TINA-QUANT HAPTOGLOBIN (K972639) | Boehringer Mannheim Corp. | 1998-01-09 |
| TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (K972640) | Boehringer Mannheim Corp. | 1998-01-09 |
| ELECSYS PSA (ON ELECSYS 1010) (K974189) | Boehringer Mannheim Corp. | 1998-01-06 |
| SPIFE IFE-6 (K973040) | Helena Laboratories | 1998-01-02 |
| DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING (K971905) | Dako Corp. | 1997-12-12 |
| CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (K974325) | Chiron Diagnostics Corp. | 1997-12-08 |
| THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR (K972790) | Theratest Laboratories, Inc. | 1997-12-05 |
| EL-B2GP1SCR (K973882) | Theratest Laboratories, Inc. | 1997-12-05 |
| MONOCOL/LEX-IM TEST (K972457) | Immunostics Inc., | 1997-12-01 |
| THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964703) | Bayer Corp. | 1997-12-01 |
| RHEUMACOL RHEUMATOID FACTOR TEST (K972456) | Immunostics Inc., | 1997-11-25 |
| SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT (K974050) | Beckman Instruments, Inc. | 1997-11-24 |
| ELECSYS AFP (K973351) | Boehringer Mannheim Corp. | 1997-11-21 |
| IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT (K973813) | Beckman Instruments, Inc. | 1997-11-20 |
| VIRGO PANCO KIT (K973824) | Hemagen Diagnostics, Inc. | 1997-11-13 |
| PR 3 ANTIBODY KIT (K973823) | Hemagen Diagnostics, Inc. | 1997-11-13 |
| VIRGO ANCA SCREEN KIT (K973822) | Hemagen Diagnostics, Inc. | 1997-11-13 |
| APO-TEK LP(A) (K970302) | Perimmune, Inc. | 1997-11-10 |
| IMX CA 15-3 (K964407) | Abbott Laboratories | 1997-11-10 |
| MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) (K965022) | Dako Corp. | 1997-11-06 |
| IMX CA 125 (K964185) | Abbott Diagnostics | 1997-11-04 |
| AXSYM CA 125 (K964020) | Abbott Laboratories | 1997-11-04 |
| TRUQUANT BR RIA (K965141) | Biomira USA, Inc. | 1997-10-31 |
| IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) (K972021) | Diagnostic Products Corp. | 1997-10-31 |
| CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964098) | Bayer Corp. | 1997-10-31 |
| IMMUNOSCAN PR3-ANCA (K971690) | Euro-Diagnostica AB | 1997-10-29 |
| IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (K971464) | Euro-Diagnostica AB | 1997-10-29 |
| ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS (K973196) | Zeus Scientific, Inc. | 1997-10-29 |
| IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT (K971689) | Euro-Diagnostica AB | 1997-10-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) (K973331) | Ortho-Clinical Diagnostics, Inc. | 1997-10-22 |
| QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) (K973464) | Instrumentation Laboratory CO | 1997-10-22 |
| QUANTA LITE B2GPI IGM (K973014) | Inova Diagnostics, Inc. | 1997-10-20 |
| ANEUVYSION (K972200) | Vysis | 1997-10-20 |
| VENTANA CD45 PRIMARY ANTIBODY (K940583) | Ventana Medical Systems, Inc. | 1997-10-20 |
| N ANTISERUM TO HUMAN ALBUMIN (K972929) | Behring Diagnostics, Inc. | 1997-10-20 |
| QUANTA LITE B2 GPI IGA (K973006) | Inova Diagnostics, Inc. | 1997-10-20 |
| N ANTISERUM TO HUMAN TRANSFERRIN (K972840) | Behring Diagnostics, Inc. | 1997-10-17 |
| CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING (K973389) | Ventana Medical Systems, Inc. | 1997-10-03 |
| AIA-PACK IGE II ASSAY (K972697) | Tosoh Medics, Inc. | 1997-10-03 |