| WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO (K001933) | Wako Chemicals USA, Inc. | 2000-07-24 |
| WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX (K001934) | Wako Chemicals USA, Inc. | 2000-07-24 |
| WAKO AUTOKIT LP(A)/DADE DEMENSION (K001919) | Wako Chemicals USA, Inc. | 2000-07-23 |
| WAKO AUTOKIT LP(A)/ RA,500/1000, (K001920) | Wako Chemicals USA, Inc. | 2000-07-23 |
| WAKO AUTOKIT LP(A)/EXPRESS 550 (K001921) | Wako Chemicals USA, Inc. | 2000-07-23 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM (K994419) | Qualisys Diagnostics, Inc. | 2000-06-28 |
| DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 (K001574) | Axis-Shield | 2000-06-09 |
| RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (K000336) | Rhigene, Inc. | 2000-06-09 |
| THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR (K001393) | Zeus Scientific, Inc. | 2000-06-07 |
| QUANTA LITE LKM-1 ELISA (K000535) | Inova Diagnostics, Inc. | 2000-06-07 |
| THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000879) | Zeus Scientific, Inc. | 2000-05-22 |
| THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000880) | Zeus Scientific, Inc. | 2000-05-22 |
| BAYER ADVIA IMS SYSTEM; 200 + 3 (K000921) | Bayer Corp. | 2000-05-18 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB (K000121) | Beckman Coulter, Inc. | 2000-05-17 |
| ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM (K000155) | Roche Diagnostics Corp. | 2000-05-17 |
| RHIGENE MESACUP2 TEST- SSA (K000749) | Rhigene, Inc. | 2000-05-09 |
| RHIGENE MESACUP2 TEST- SM (K000755) | Rhigene, Inc. | 2000-05-09 |
| RHIGENE MESACUP2 TEST- SCL-70 (K000750) | Rhigene, Inc. | 2000-05-09 |
| NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (K994140) | Nichols Institute Diagnostics | 2000-05-09 |
| RHIGENE MESACUP2 TEST- SSB (K000751) | Rhigene, Inc. | 2000-05-09 |
| RHIGENE MESACUP2 TEST- RNP (K000752) | Rhigene, Inc. | 2000-05-09 |
| BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT (K991802) | The Binding Site, Ltd. | 2000-05-05 |
| BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT (K991801) | The Binding Site, Ltd. | 2000-05-05 |
| BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. (K991803) | The Binding Site, Ltd. | 2000-05-05 |
| BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. (K991804) | The Binding Site, Ltd. | 2000-05-05 |
| HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER (K000701) | The Binding Site, Ltd. | 2000-04-27 |
| REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT (K000920) | Corgenix, Inc. | 2000-04-26 |
| MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K001118) | DiaSorin, Inc. | 2000-04-25 |
| RANDOX PREALBUMIN (K000661) | Randox Laboratories, Ltd. | 2000-04-13 |
| BAYER PSA ASSAY (K994221) | Bayer Corp. | 2000-04-13 |
| MDI SCL-70 TEST (K000934) | Micro Detect, Inc. | 2000-04-07 |
| ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (K000489) | Helix Diagnostics, Inc. | 2000-04-05 |
| COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II (K000534) | Roche Diagnostics Corp. | 2000-04-05 |
| RANDOX FERRITIN (K000662) | Randox Laboratories, Ltd. | 2000-04-03 |
| RANDOX COMPLEMENT C3 (K000469) | Randox Laboratories, Ltd. | 2000-03-27 |
| RANDOX COMPLEMENT C4 (K000468) | Randox Laboratories, Ltd. | 2000-03-27 |
| VARELISA SM ANTIBODIES (K000312) | Pharmacia & Upjohn Co. | 2000-03-17 |
| BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO (K000287) | Brahms Diagnostica, LLC | 2000-03-17 |
| BRAHMS DIAGNOSTICA LUMITEST ANTI-TG (K000286) | Brahms Diagnostica, LLC | 2000-03-17 |
| MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS (K000566) | Ortho-Clinical Diagnostics, Inc. | 2000-03-09 |
| AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (K993557) | Cogent Diagnotics , Ltd. | 2000-03-03 |
| MDI DS-DNA TEST (K000477) | Micro Detect, Inc. | 2000-03-01 |
| DIMENSION C3 FLEX REAGENT CARTRIDGE (K994296) | Dade Behring, Inc. | 2000-03-01 |
| DIMENSION C4 FLEX REAGENT CARTRIDGE (K994293) | Dade Behring, Inc. | 2000-03-01 |
| ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 (K000132) | Pharmacia & Upjohn Co. | 2000-02-18 |
| DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (K994424) | Diamedix Corp. | 2000-02-18 |
| ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 (K000196) | Beckman Coulter, Inc. | 2000-02-18 |
| EU-TTG IGA ELISA (K994379) | Scimedx Corp. | 2000-02-18 |
| MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM (K000362) | Zeus Scientific, Inc. | 2000-02-18 |
| MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K000363) | Zeus Scientific, Inc. | 2000-02-18 |
| DIMENSION TRNF FLEX REAGENT CARTRIDGE (K994294) | Dade Behring, Inc. | 2000-02-04 |
| AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (K994338) | Cogent Diagnotics , Ltd. | 2000-02-03 |
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR (K993549) | Beckman Coulter, Inc. | 2000-02-01 |
| AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (K993085) | Cogent Diagnotics , Ltd. | 2000-02-01 |
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB (K993547) | Beckman Coulter, Inc. | 2000-02-01 |
| WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928) | Wako Chemicals USA, Inc. | 2000-01-18 |
| RHIGENE ANA ELISA TEST SYSTEM (K994071) | Rhigene, Inc. | 2000-01-18 |
| WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927) | Wako Chemicals USA, Inc. | 2000-01-14 |
| WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993924) | Wako Chemicals USA, Inc. | 2000-01-14 |
| ENA PROFILE ELISA TEST SYSTEM (K993839) | Trinity Biotech USA | 2000-01-12 |
| MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM (K993971) | Micro Detect, Inc. | 2000-01-11 |
| MDI SM TEST (K994029) | Micro Detect, Inc. | 2000-01-11 |
| MDI RF TEST (K993843) | Micro Detect, Inc. | 2000-01-11 |
| MDI SM/RNP TEST (K993635) | Micro Detect, Inc. | 2000-01-10 |
| MDI SS-A TEST (K993636) | Micro Detect, Inc. | 2000-01-10 |
| VARELISA TPO ANTIBODIES, MODEL 12348/12396 (K993585) | Pharmacia & Upjohn Co. | 2000-01-05 |
| BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA (K993612) | The Binding Site, Ltd. | 1999-12-21 |
| LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K994110) | Diasorin/American Standard Companies | 1999-12-21 |
| IGM MININEPH ANTISERUM (K981784) | The Binding Site, Ltd. | 1999-12-21 |
| BINDAZYME ANTI-DSDNA EIA KIT (K993727) | The Binding Site, Ltd. | 1999-12-21 |
| C4 MININEPH ANTISERUM (K981785) | The Binding Site, Ltd. | 1999-12-20 |
| C3 MININEPH ANTISERUM (K981783) | The Binding Site, Ltd. | 1999-12-20 |
| IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS (K982100) | The Binding Site, Ltd. | 1999-12-20 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711) | Bayer Corp. | 1999-12-16 |
| AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (K993304) | Cogent Diagnotics , Ltd. | 1999-12-06 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 (K992188) | Nichols Institute Diagnostics | 1999-12-06 |
| ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F (K993388) | Pharmacia & Upjohn Co. | 1999-12-01 |
| K-ASSAY IGM (K993323) | Kamiya Biomedical Co. | 1999-11-30 |
| K-ASSAY TRANSFERRIN (K993537) | Kamiya Biomedical Co. | 1999-11-30 |
| K-ASSAY C4 (K993481) | Kamiya Biomedical Co. | 1999-11-29 |
| VARELISA RNP ANTIBODIES (K993589) | Pharmacia & Upjohn Co. | 1999-11-26 |
| MACRA LP(A) ENZYME IMMUNOASSAY KIT (K992665) | Trinity Biotech USA | 1999-11-26 |
| K-ASSAY HAPTOGLOBIN (K993480) | Kamiya Biomedical Co. | 1999-11-24 |
| K-ASSAY C3 (K993437) | Kamiya Biomedical Co. | 1999-11-24 |
| K-ASSAY ALPHA-1 AT (K993444) | Kamiya Biomedical Co. | 1999-11-24 |
| K-ASSAY ALPHA-1 AG (K993441) | Kamiya Biomedical Co. | 1999-11-24 |
| IGA MININEPH ANTISERUM (K981786) | The Binding Site, Ltd. | 1999-11-24 |
| AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (K992449) | Cogent Diagnotics , Ltd. | 1999-11-24 |
| N LATEX FERRITIN (K993273) | Dade Behring, Inc. | 1999-11-23 |
| K-ASSAY IGA (K993213) | Kamiya Biomedical Co. | 1999-11-23 |
| LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K993669) | DiaSorin, Inc. | 1999-11-17 |
| BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO (K992791) | Brahms Diagnostica, LLC | 1999-11-12 |
| BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG (K992790) | Brahms Diagnostica, LLC | 1999-11-12 |
| THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. (K993250) | Zeus Scientific, Inc. | 1999-11-12 |
| VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (K993108) | Pharmacia & Upjohn Co. | 1999-11-12 |
| AUTOSTAT II ANTI-GLIADIN IGG ELISA (K993087) | Cogent Diagnotics , Ltd. | 1999-11-12 |
| AUTOSTAT II ANTI-GLIADIN IGA ELISA (K993086) | Cogent Diagnotics , Ltd. | 1999-11-12 |
| WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR (K993162) | Wako Chemicals USA, Inc. | 1999-11-12 |
| VARELISA RECOMBI ANA PROFILE (K993109) | Pharmacia & Upjohn Co. | 1999-11-12 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991907) | Bayer Corp. | 1999-11-09 |