| K-ASSAY IGG (K993281) | Kamiya Biomedical Co. | 1999-11-09 |
| MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD (K993034) | Medica, Inc. | 1999-11-01 |
| K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR (K992976) | Kamiya Biomedical Co. | 1999-11-01 |
| K-ASSAY APO B (K993354) | Kamiya Biomedical Co. | 1999-10-28 |
| K-ASSAY APO AI (K993345) | Kamiya Biomedical Co. | 1999-10-25 |
| DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM (K993294) | Diamedix Corp. | 1999-10-25 |
| DADE BEHRING N HIGH SENSITIVITY CRP ASSAY (K991385) | Dade Behring, Inc. | 1999-10-25 |
| ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST (K992878) | Immco Diagnostics, Inc. | 1999-10-15 |
| BIOCHECK FERRITIN ELISA MODEL BC-1025 (K992517) | Biocheck, Inc. | 1999-09-24 |
| BIOCHECK IGE ELISA, MODEL BC-1035 (K992528) | Biocheck, Inc. | 1999-09-21 |
| AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (K992440) | Cogent Diagnotics , Ltd. | 1999-09-21 |
| TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488) | The Binding Site, Ltd. | 1999-09-17 |
| K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC (K992311) | Kamiya Biomedical Co. | 1999-09-13 |
| K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B (K992312) | Kamiya Biomedical Co. | 1999-09-13 |
| VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT (K992241) | Hemagen Diagnostics, Inc. | 1999-08-30 |
| VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT (K992224) | Hemagen Diagnostics, Inc. | 1999-08-30 |
| VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT (K992243) | Hemagen Diagnostics, Inc. | 1999-08-30 |
| AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (K991942) | Cogent Diagnotics , Ltd. | 1999-08-24 |
| KRONUS OPTIQUANT THYROGLOBULIN KIT (K991720) | Unchanged | 1999-08-09 |
| TOUCH TEAR IGE MICROASSAY KIT (K991316) | Touch Scientific, Inc. | 1999-08-09 |
| AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (K991890) | Cogent Diagnotics , Ltd. | 1999-08-09 |
| CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (K992157) | Chiron Diagnostics Corp. | 1999-08-05 |
| N LATEX STFR REAGENT (K991157) | Dade Behring, Inc. | 1999-08-02 |
| PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (K991945) | Pharmacia & Upjohn Co. | 1999-07-28 |
| RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (K992041) | Immuno Concepts, Inc. | 1999-07-23 |
| QUALISYS PSA IMMUNOASSAY (K990234) | Qualisys Diagnostics, Inc. | 1999-07-08 |
| N LATEX IGE MONO REAGENT (K991787) | Dade Behring, Inc. | 1999-07-07 |
| POLYSLIT IFE KIT (K990998) | Helena Laboratories | 1999-06-28 |
| ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (K991610) | Zeus Scientific, Inc. | 1999-06-25 |
| DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138) | Diagnostic Systems Laboratories, Inc. | 1999-06-21 |
| ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K991179) | Zeus Scientific, Inc. | 1999-06-17 |
| QUANTA LITE ANA ELISA (K991657) | Inova Diagnostics, Inc. | 1999-06-17 |
| K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET (K991467) | Kamiya Biomedical Co. | 1999-06-10 |
| IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 (K991796) | Diagnostic Products Corp. | 1999-06-09 |
| K-ASSAY RHEUMATOID FACTOR (K991409) | Kamiya Biomedical Co. | 1999-06-09 |
| AIA-PACK CA 125 (K990431) | Tosoh Medics, Inc. | 1999-06-03 |
| MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 (K991707) | Beckman | 1999-06-01 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943) | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 |
| CRP (K991372) | Abbott Laboratories | 1999-06-01 |
| THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K983715) | Bayer Corp. | 1999-05-14 |
| K-ASSAY CRP (K991224) | Kamiya Biomedical Co. | 1999-05-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK (K983875) | Ortho-Clinical Diagnostics, Inc. | 1999-05-14 |
| ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 (K991048) | Pharmacia & Upjohn Co. | 1999-05-14 |
| IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 (K991094) | Diagnostic Products Corp. | 1999-05-13 |
| IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 (K991096) | Diagnostic Products Corp. | 1999-05-13 |
| K-ASSAY CRP CALIBRATOR SET (K991210) | Kamiya Biomedical Co. | 1999-05-11 |
| ABBOTT ARCHITECT CEA (K990774) | Abbott Laboratories | 1999-05-11 |
| B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM (K991136) | Olympus America, Inc. | 1999-05-11 |
| ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT (K990704) | Beckman Coulter, Inc. | 1999-05-03 |
| AUTOSTAT II ANTI-SM/RNP ELISA (K990624) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-JO-1 ELISA (K990798) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-SS-B/LA ELISA (K990626) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-SCL-70 ELISA (K990797) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-SS-A/RO ELISA (K990627) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-SM ELISA (K990625) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA (K990796) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 (K991277) | Diagnostic Products Corp. | 1999-04-27 |
| INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (K990915) | Stellar Bio Systems, Inc. | 1999-04-21 |
| INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (K990916) | Stellar Bio Systems, Inc. | 1999-04-21 |
| REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE (K990825) | Dade Behring, Inc. | 1999-04-16 |
| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594) | Roche Diagnostics Corp. | 1999-04-14 |
| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B (K990595) | Roche Diagnostics Corp. | 1999-04-14 |
| ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 (K990587) | Bio-Rad | 1999-04-07 |
| IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 (K990886) | Diagnostic Products Corp. | 1999-04-06 |
| SPQ TEST SYSTEM (K982708) | DiaSorin, Inc. | 1999-04-02 |
| GLIADIN IGG ELISA TEST SYSTEM (K990204) | Zeus Scientific, Inc. | 1999-03-26 |
| GLIADIN IGA ELISA TEST SYSTEM (K990207) | Zeus Scientific, Inc. | 1999-03-26 |
| IMMUNOGLOBULIN A TEST SYSTEM (K990552) | Dade Behring, Inc. | 1999-03-25 |
| IGG FLEX REAGENT CARTRIDGE (K990551) | Dade Behring, Inc. | 1999-03-25 |
| IGM FLEX REAGENT CARTRIDGE (K990553) | Dade Behring, Inc. | 1999-03-22 |
| ACL/APS FACS KIT (K984102) | Louisville Apl Diagnostics, Inc. | 1999-03-18 |
| IMMULITE THYROGLOBULIN MODEL LKTY (K982466) | Diagnostic Products Corp. | 1999-03-12 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK (K984289) | Ortho-Clinical Diagnostics, Inc. | 1999-03-12 |
| IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468) | Diagnostic Products Corp. | 1999-03-12 |
| WAKO AUTOKIT LP(A) (K981446) | Wako Chemicals USA, Inc. | 1999-03-09 |
| RF (K990035) | Abbott Laboratories | 1999-03-08 |
| BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619) | The Binding Site, Ltd. | 1999-02-23 |
| GLIADIN ANTIBODIES ELISA (K973910) | Genesis Diagnostics , Ltd. | 1999-02-17 |
| QUANTA LITE GBM ELISA (K984336) | Inova Diagnostics, Inc. | 1999-02-08 |
| ELECYS IGE ASSAY (K984326) | Boehringer Mannheim Corp. | 1999-02-08 |
| ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT (K983694) | The Binding Site, Ltd. | 1999-02-05 |
| ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST (K983692) | The Binding Site, Ltd. | 1999-02-05 |
| ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT (K983695) | The Binding Site, Ltd. | 1999-02-05 |
| ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT (K983696) | The Binding Site, Ltd. | 1999-02-05 |
| ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT (K984165) | The Binding Site, Ltd. | 1999-02-02 |
| ANTI-TPO EIA DIAGNOSTIC TEST KIT (K984163) | The Binding Site, Ltd. | 1999-02-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK (K983690) | Ortho-Clinical Diagnostics, Inc. | 1999-02-02 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY (K984186) | Nichols Institute Diagnostics | 1999-02-02 |
| IS ANTI-TPO IGG ELISA TEST SYSTEM (K984228) | Columbia Bioscience, Inc. | 1999-02-02 |
| APOLIPOPROTEIN A1 (K983289) | Abbott Laboratories | 1999-01-29 |
| AUTOSTAT II ANA SCREEN ELISA (K983655) | Cogent Diagnotics , Ltd. | 1999-01-28 |
| IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 (K984132) | Diagnostic Products Corp. | 1999-01-28 |
| DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (K982634) | Oxoid , Ltd. | 1999-01-28 |
| QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA (K984137) | Inova Diagnostics, Inc. | 1999-01-28 |
| NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY (K983992) | Nichols Institute Diagnostics | 1999-01-26 |
| APOB (K983281) | Abbott Laboratories | 1999-01-26 |
| RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS (K984045) | Kamiya Biomedical Co. | 1999-01-25 |
| THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (K984516) | Zeus Scientific, Inc. | 1999-01-11 |
| AUTOSTAT II ENA SCREEN ELISA (K983921) | Cogent Diagnotics , Ltd. | 1998-12-28 |
| OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT (K984145) | Olympus Diagnostica GmbH | 1998-12-23 |