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Immunology

3,537 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB (K012292)The Binding Site, Ltd.2001-08-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T (K012296)The Binding Site, Ltd.2001-08-31
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (K012567)Corgenix, Inc.2001-08-23
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T (K012295)The Binding Site, Ltd.2001-08-20
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (K012053)Diamedix Corp.2001-08-20
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA (K012291)The Binding Site, Ltd.2001-08-20
POLYTITER SYSTEM (K012163)Polymedco, Inc.2001-08-20
AIA-PACK BRCA, ST AIA PACK BRCA (K010796)Tosoh Medics, Inc.2001-08-16
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (K011031)Vysis2001-08-03
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (K011663)The Binding Site, Ltd.2001-07-30
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL (K011662)The Binding Site, Ltd.2001-07-30
QUANTA PLEX ENA PROFILE 4 (K011140)Inova Diagnostics, Inc.2001-07-27
K-ASSAY C1-INA (K011780)Kamiya Biomedical Co.2001-07-25
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 (K003851)Biocheck, Inc.2001-07-20
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA (K011566)Inova Diagnostics, Inc.2001-07-09
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA (K011570)Inova Diagnostics, Inc.2001-07-09
PHASE II GBM IGG ANTIBODY EIA TEST (K011348)Scimedx Corp.2001-06-25
WAKO AUTOKIT C3 (K010326)Wako Chemicals USA, Inc.2001-06-25
WAKO AUTOKIT C4 (K010325)Wako Chemicals USA, Inc.2001-06-25
IBD-CHEK (K011396)Techlab, Inc.2001-06-18
TPO IGG ANTIBODY EIA TEST (K011082)Scimedx Corp.2001-06-06
ALPCO MILENIA ANTI-TG EIA (K011415)American Laboratory Products Co., Ltd.2001-05-30
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT (K010597)Beckman Coulter, Inc.2001-05-29
ALPCO MILENIA ANTI-TPO ELISA (K011201)American Laboratory Products Co., Ltd.2001-05-24
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (K000733)Inova Diagnostics, Inc.2001-05-21
TINA-QUANT ALPHA-1 ANTITRYPSIN (K010978)Rochdiag2001-05-18
K-ASSAY HS-CRP CONTROLS (K011079)Kamiya Biomedical Co.2001-05-16
RANDOX IGE (K010855)Randox Laboratories, Ltd.2001-05-15
CRP HS TEST SYSTEM (K003400)Roche Diagnostics Corp.2001-05-10
RANDOX MYOGLOBIN (K010700)Randox Laboratories, Ltd.2001-05-08
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 (K003064)Roche Diagnostics Corp.2001-05-01
FREELITE LAMBDA FREE KIT (K010440)The Binding Site, Ltd.2001-04-26
FREELITE KAPPA FREE KIT (K010441)The Binding Site, Ltd.2001-04-26
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550)bioMerieux, Inc.2001-04-24
EUROSPITAL EU-TTG IGA UMANA (K010625)Scimedx Corp.2001-04-24
ANEUVYSION MULITICOLOR DNA PROBE KIT (K010288)Vysis2001-04-13
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001352)Corgenix, Inc.2001-04-09
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT (K010236)Beckman Coulter, Inc.2001-04-05
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558)Inova Diagnostics, Inc.2001-04-03
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001398)Corgenix, Inc.2001-03-30
ELECSYSCA 15-3 II ASSAY (K010588)Roche Diagnostics Corp.2001-03-28
C1-INHIBITOR MICROTITER ASSAY DEVICE (K003747)Baxter Healthcare Corp2001-03-19
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (K010287)Scimedx Corp.2001-03-16
SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617)Helena Laboratories2001-03-15
SCIMEDX PHASE II MPO IGG ANTIBODY EIA (K010289)Scimedx Corp.2001-03-07
ENA EIA KIT RANGE (K010146)The Binding Site, Ltd.2001-03-01
ENA EIA KIT (K010147)The Binding Site, Ltd.2001-03-01
DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963)Dade Behring, Inc.2001-02-28
ENA SCREEN EIA KIT (K010148)The Binding Site, Ltd.2001-02-23
ANA EIA DIAGNOSTIC TEST KIT (K004019)The Binding Site, Ltd.2001-02-15
RCRP FLEX REAGENT CARTRIDGE (K003419)Dade Behring, Inc.2001-02-14
RANDOX TRANSFERRIN (K002585)Randox Laboratories, Ltd.2001-02-05
KAPPA IMMAGE FREELITE KIT (K003669)The Binding Site, Ltd.2001-02-01
LAMBDA IMMAGE FREELITE KIT (K003671)The Binding Site, Ltd.2001-02-01
WAKO CRP-UL, CRP-UL CALIBRATOR SET (K003342)Wako Chemicals USA, Inc.2001-01-22
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA (K003959)Inova Diagnostics, Inc.2001-01-22
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP (K003372)Diagnostic Products Corp.2000-12-26
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY (K003291)Bayer Diagnostics Corp.2000-12-05
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (K003069)Quest Intl., Inc.2000-11-27
VARELISA TG (THYROGLOBULIN) ANTIBODIES, (K003414)Pharmacia & Upjohn Co.2000-11-27
N LATEX B2-MICROGLOBULIN (K002731)Dade Behring, Inc.2000-11-20
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563)The Binding Site, Ltd.2000-10-26
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002564)The Binding Site, Ltd.2000-10-26
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT (K002560)The Binding Site, Ltd.2000-10-26
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376)Bayer Corp.2000-10-26
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (K002561)The Binding Site, Ltd.2000-10-26
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE (K002558)Kamiya Biomedical Co.2000-10-25
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K002918)Olympus America, Inc.2000-10-25
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094)Qualigen, Inc.2000-10-25
ELECSYS CA 15-3 TEST SYSTEM (K001468)Roche Diagnostics Corp.2000-10-23
NICHOLS ADVANTAGE THYROGLOB (K002888)Nichols Institute Diagnostics2000-10-20
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (K002169)Scimedx Corp.2000-10-19
MDI GLIADIN A TEST (K002358)Micro Detect, Inc.2000-10-19
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (K002189)Scimedx Corp.2000-10-19
MDI GLIADIN G TEST (K002359)Micro Detect, Inc.2000-10-19
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905)Beckman Coulter, Inc.2000-10-19
AUTOSTAT II ENA-6 PROFILE ELISA (K003054)Cogent Diagnotics , Ltd.2000-10-13
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET (K002651)Pointe Scientific, Inc.,2000-10-13
AUTOSTAT II ENA-4 PROFILE ELISA (K003057)Cogent Diagnotics , Ltd.2000-10-13
RANDOX MICROALBUMIN (K002674)Randox Laboratories, Ltd.2000-10-05
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 (K002799)Beckman Coulter, Inc.2000-10-05
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) (K994112)Oncogene Science, Inc.2000-09-29
BAYER IMMUNO 1 HER-2/NEU ASSAY (K992228)Bayer Corp.2000-09-29
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (K002215)Cogent Diagnotics , Ltd.2000-09-28
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (K001022)Biocheck, Inc.2000-09-26
BN PROSPEC SYSTEM (K001647)Dade Behring, Inc.2000-09-26
EL-ANA PROFILES-2K1 (K002559)Theratest Laboratories, Inc.2000-09-12
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (K001900)Helix Diagnostics, Inc.2000-09-11
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609)Roche Diagnostics Corp.2000-09-05
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY (K001127)The Binding Site, Ltd.2000-08-30
TOTAL PSA MICROTITER ELISA (K002121)Oncogene Science, Inc.2000-08-30
COMPLEXED PSA MICROTITER ELISA (K002313)Oncogene Science, Inc.2000-08-30
C-REACTIVE PROTEIN ANTISERUM KIT (K001636)The Binding Site, Ltd.2000-08-24
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 (K001981)Axis-Shield , Ltd.2000-08-21
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY (K001556)The Binding Site, Ltd.2000-08-21
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007)Inova Diagnostics, Inc.2000-08-16
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. (K002107)Scimedx Corp.2000-08-04
RANDOX C-REACTIVE PROTEIN (K001009)Randox Laboratories, Ltd.2000-08-04
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET (K001931)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA (K001929)Wako Chemicals USA, Inc.2000-07-24
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