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Ortho Diagnostic Systems, Inc.

126 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (K951459)Ortho Diagnostic Systems, Inc.1997-07-14
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (K951632)Ortho Diagnostic Systems, Inc.1997-03-06
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (K964754)Ortho Diagnostic Systems, Inc.1997-01-22
QUANTITATIVE FIBRINOGEN ASSAY (K963902)Ortho Diagnostic Systems, Inc.1996-11-29
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (K950568)Ortho Diagnostic Systems, Inc.1996-05-13
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950625)Ortho Diagnostic Systems, Inc.1996-05-13
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (K951100)Ortho Diagnostic Systems, Inc.1996-05-13
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950482)Ortho Diagnostic Systems, Inc.1996-05-10
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM (K935720)Ortho Diagnostic Systems, Inc.1996-05-09
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (K954570)Ortho Diagnostic Systems, Inc.1996-04-30
SYNTHAFAX APTT REAGENT (K955638)Ortho Diagnostic Systems, Inc.1996-04-23
SYNTHASIL APTT REAGENT (K953981)Ortho Diagnostic Systems, Inc.1995-11-30
ORTHO ALT MICROWELL TEST SYSTEM (K941192)Ortho Diagnostic Systems, Inc.1995-05-16
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL (K940209)Ortho Diagnostic Systems, Inc.1995-05-11
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT (K935748)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) (K932532)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE (K932531)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) (K932530)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) (K941713)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS (K931443)Ortho Diagnostic Systems, Inc.1993-11-05
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA (K930002)Ortho Diagnostic Systems, Inc.1993-07-16
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (K930020)Ortho Diagnostic Systems, Inc.1993-07-16
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT (K925604)Ortho Diagnostic Systems, Inc.1993-03-12
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION (K925208)Ortho Diagnostic Systems, Inc.1992-12-28
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM (K914188)Ortho Diagnostic Systems, Inc.1992-08-26
ORTHO CHLAMYDIA ANTIGEN ELISA TEST (K921321)Ortho Diagnostic Systems, Inc.1992-08-11
MODIFIED ORTHO EBV VCA-IGG ELISA (K920412)Ortho Diagnostic Systems, Inc.1992-06-22
ORTHO HSV ANTIGEN ELISA TEST (K915551)Ortho Diagnostic Systems, Inc.1992-04-22
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570)Ortho Diagnostic Systems, Inc.1991-06-10
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571)Ortho Diagnostic Systems, Inc.1991-06-10
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST (K911569)Ortho Diagnostic Systems, Inc.1991-06-10
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY (K904253)Ortho Diagnostic Systems, Inc.1991-05-20
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION (K910668)Ortho Diagnostic Systems, Inc.1991-03-19
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF (K903132)Ortho Diagnostic Systems, Inc.1990-12-21
ORTHO CMV-M ANTIBODY ELISA TEST (K905077)Ortho Diagnostic Systems, Inc.1990-12-17
ORTHO CMV-G ANTIBODY ELISA TEST (K905078)Ortho Diagnostic Systems, Inc.1990-12-17
ORTHO RUBELLA-M ANTIBODY ELISA TEST (K905079)Ortho Diagnostic Systems, Inc.1990-12-04
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA (K902210)Ortho Diagnostic Systems, Inc.1990-07-03
ORTHO CORRECTION REAGENTS (K901327)Ortho Diagnostic Systems, Inc.1990-05-25
KOAGULAB 60-S COAGULATION SYSTEM (K901120)Ortho Diagnostic Systems, Inc.1990-05-22
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA (K901233)Ortho Diagnostic Systems, Inc.1990-04-11
ORTHOKROME* FACTOR VIII (K900395)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* HEPARIN (K900396)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* ANTITHROMBIN (K900400)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* ANTIPLASMIN (K900397)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PROTEIN C (K900398)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PLASMINOGEN (K900399)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHO* RUBELLA-G ANTIBODY ELISA TEST (K896479)Ortho Diagnostic Systems, Inc.1989-12-29
ORTHO RESULT PLUS/PREGNANCY (K894420)Ortho Diagnostic Systems, Inc.1989-10-04
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES (K891382)Ortho Diagnostic Systems, Inc.1989-06-06
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST (K883937)Ortho Diagnostic Systems, Inc.1989-02-07
KOAGULAB* 32-S COAGULATION SYSTEM (K885035)Ortho Diagnostic Systems, Inc.1989-02-03
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY (K884617)Ortho Diagnostic Systems, Inc.1989-02-02
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST (K883935)Ortho Diagnostic Systems, Inc.1989-01-04
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST (K883940)Ortho Diagnostic Systems, Inc.1989-01-04
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST (K883939)Ortho Diagnostic Systems, Inc.1988-12-22
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST (K883938)Ortho Diagnostic Systems, Inc.1988-12-22
ORTHO FACTOR XII DEFICIENT PLASMA (K883688)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO OWREN'S BUFFER (K883689)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR XI DEFICIENT PLASMA (K883691)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR X DEFICIENT PLASMA (K883690)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR VII DEFICIENT PLASMA (K883692)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST (K883936)Ortho Diagnostic Systems, Inc.1988-10-06
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (K881932)Ortho Diagnostic Systems, Inc.1988-08-01
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. (K872541)Ortho Diagnostic Systems, Inc.1988-05-13
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (K881500)Ortho Diagnostic Systems, Inc.1988-04-27
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH (K875162)Ortho Diagnostic Systems, Inc.1988-01-27
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST (K872628)Ortho Diagnostic Systems, Inc.1987-12-21
RESULT PLUS/HCG PREGNANCY TEST (K872730)Ortho Diagnostic Systems, Inc.1987-10-20
ORTHO* SPECIMEN COLLECTION CYTOBRUSH (K871552)Ortho Diagnostic Systems, Inc.1987-06-26
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT (K863490)Ortho Diagnostic Systems, Inc.1986-11-05
KOAGULAB* M COAGULATION SYSTEM (K862537)Ortho Diagnostic Systems, Inc.1986-07-21
ORTHO HSV ANTIGEN ELISA TEST (K854488)Ortho Diagnostic Systems, Inc.1986-02-04
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST (K853738)Ortho Diagnostic Systems, Inc.1985-12-06
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS (K853328)Ortho Diagnostic Systems, Inc.1985-11-05
ORTHO DNA PROBE HSV CONFIRMATION TEST (K852360)Ortho Diagnostic Systems, Inc.1985-09-12
ORTHO VIRAL TRANSPORT (K853500)Ortho Diagnostic Systems, Inc.1985-08-28
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L (K852834)Ortho Diagnostic Systems, Inc.1985-08-08
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL (K851641)Ortho Diagnostic Systems, Inc.1985-07-23
CULTURESET HSV ISOLATION & ID SYS (K842216)Ortho Diagnostic Systems, Inc.1985-01-29
ORTHO BRAIN THROMBOPLASTIN DILUENT (K843535)Ortho Diagnostic Systems, Inc.1984-12-12
ORTHO* RSV ANTIGEN ELISA TEST SYS (K842047)Ortho Diagnostic Systems, Inc.1984-10-05
ORTHO RESPIRATORY SYNCYTIAL VIRUS- (K841527)Ortho Diagnostic Systems, Inc.1984-08-12
ORTHO VARICELLA-ZOSTER VIRUS IDENT. (K841526)Ortho Diagnostic Systems, Inc.1984-06-25
ORTHO* SERUM ELISA TEST SYSTEM (K833636)Ortho Diagnostic Systems, Inc.1984-06-13
ORTHO MICROWELL READER (K841557)Ortho Diagnostic Systems, Inc.1984-05-22
RUBELLA IGG ANTIBODY ELISA TEST SYS (K841200)Ortho Diagnostic Systems, Inc.1984-05-21
HSV ANTIGEN ELISA KIT (K834449)Ortho Diagnostic Systems, Inc.1984-05-02
ORTHO BI-LEVEL RECEPTOR CONTROL (K834064)Ortho Diagnostic Systems, Inc.1984-03-23
ORTHO BACTERIURIA DETECTION SYS (K833834)Ortho Diagnostic Systems, Inc.1984-03-12
ORTHO B-HCG SLIDE TEST FOR PREGNANCY (K833137)Ortho Diagnostic Systems, Inc.1984-01-18
ORTHO ELT-8/DS HEMATOLOGY ANALYZER (K833618)Ortho Diagnostic Systems, Inc.1984-01-13
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO (K832947)Ortho Diagnostic Systems, Inc.1983-09-29
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO (K831670)Ortho Diagnostic Systems, Inc.1983-08-24
ORTHO ABNORMAL COAGULATION LEVEL I/II (K832225)Ortho Diagnostic Systems, Inc.1983-08-12
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG (K831271)Ortho Diagnostic Systems, Inc.1983-07-26
TRI-LEVEL TDM CONTROL & I II III (K831500)Ortho Diagnostic Systems, Inc.1983-06-30
ORTHO RUBELLA ELISA TEST SYSTEM (K822342)Ortho Diagnostic Systems, Inc.1983-03-17
MANUALISA MICROTITRATION PLATE READER (K823590)Ortho Diagnostic Systems, Inc.1983-02-28
ORTHO BI-LEVEL ASSAYED LIPID PROFILE (K823490)Ortho Diagnostic Systems, Inc.1983-01-05
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