This page includes the latest FDA filings for Ortho Diagnostic Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | 1997-07-14 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | 1997-03-06 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | 1997-01-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | QUANTITATIVE FIBRINOGEN ASSAY | 1996-11-29 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | 1996-05-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | 1996-05-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | 1996-05-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | 1996-05-10 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | 1996-05-09 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | 1996-04-30 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | SYNTHAFAX APTT REAGENT | 1996-04-23 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | SYNTHASIL APTT REAGENT | 1995-11-30 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO ALT MICROWELL TEST SYSTEM | 1995-05-16 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL | 1995-05-11 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) | 1995-04-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | 1995-04-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) | 1995-04-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE | 1995-04-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) | 1995-04-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | 1993-11-05 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | 1993-07-16 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | 1993-07-16 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT | 1993-03-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | 1992-12-28 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM | 1992-08-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CHLAMYDIA ANTIGEN ELISA TEST | 1992-08-11 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | MODIFIED ORTHO EBV VCA-IGG ELISA | 1992-06-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO HSV ANTIGEN ELISA TEST | 1992-04-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | 1991-06-10 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | 1991-06-10 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | 1991-06-10 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY | 1991-05-20 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION | 1991-03-19 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CMV-G ANTIBODY ELISA TEST | 1990-12-17 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CMV-M ANTIBODY ELISA TEST | 1990-12-17 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RUBELLA-M ANTIBODY ELISA TEST | 1990-12-04 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA | 1990-07-03 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CORRECTION REAGENTS | 1990-05-25 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB 60-S COAGULATION SYSTEM | 1990-05-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA | 1990-04-11 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* ANTITHROMBIN | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* PLASMINOGEN | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* PROTEIN C | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* ANTIPLASMIN | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* HEPARIN | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHOKROME* FACTOR VIII | 1990-03-15 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* RUBELLA-G ANTIBODY ELISA TEST | 1989-12-29 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RESULT PLUS/PREGNANCY | 1989-10-04 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | 1989-06-06 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST | 1989-02-07 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB* 32-S COAGULATION SYSTEM | 1989-02-03 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY | 1989-02-02 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST | 1989-01-04 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST | 1989-01-04 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* SYPHILIS-G ANTIBODY ELISA TEST | 1988-12-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* SYPHILIS-M ANTIBODY ELISA TEST | 1988-12-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO FACTOR VII DEFICIENT PLASMA | 1988-11-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO FACTOR XI DEFICIENT PLASMA | 1988-11-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO FACTOR X DEFICIENT PLASMA | 1988-11-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO OWREN'S BUFFER | 1988-11-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO FACTOR XII DEFICIENT PLASMA | 1988-11-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST | 1988-10-06 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT | 1988-08-01 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. | 1988-05-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST | 1988-04-27 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH | 1988-01-27 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST | 1987-12-21 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | RESULT PLUS/HCG PREGNANCY TEST | 1987-10-20 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* SPECIMEN COLLECTION CYTOBRUSH | 1987-06-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT | 1986-11-05 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB* M COAGULATION SYSTEM | 1986-07-21 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO HSV ANTIGEN ELISA TEST | 1986-02-04 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST | 1985-12-06 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS | 1985-11-05 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO DNA PROBE HSV CONFIRMATION TEST | 1985-09-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO VIRAL TRANSPORT | 1985-08-28 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L | 1985-08-08 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL | 1985-07-23 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | CULTURESET HSV ISOLATION & ID SYS | 1985-01-29 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO BRAIN THROMBOPLASTIN DILUENT | 1984-12-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* RSV ANTIGEN ELISA TEST SYS | 1984-10-05 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RESPIRATORY SYNCYTIAL VIRUS- | 1984-08-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | 1984-06-25 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO* SERUM ELISA TEST SYSTEM | 1984-06-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO MICROWELL READER | 1984-05-22 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | RUBELLA IGG ANTIBODY ELISA TEST SYS | 1984-05-21 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | HSV ANTIGEN ELISA KIT | 1984-05-02 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO BI-LEVEL RECEPTOR CONTROL | 1984-03-23 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO BACTERIURIA DETECTION SYS | 1984-03-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO B-HCG SLIDE TEST FOR PREGNANCY | 1984-01-18 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO ELT-8/DS HEMATOLOGY ANALYZER | 1984-01-13 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO | 1983-09-29 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | 1983-08-24 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO ABNORMAL COAGULATION LEVEL I/II | 1983-08-12 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG | 1983-07-26 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | TRI-LEVEL TDM CONTROL & I II III | 1983-06-30 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO RUBELLA ELISA TEST SYSTEM | 1983-03-17 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | MANUALISA MICROTITRATION PLATE READER | 1983-02-28 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO BI-LEVEL ASSAYED LIPID PROFILE | 1983-01-05 |
ORTHO DIAGNOSTIC SYSTEMS, INC. | KOAGULAB 40-A AUTOMATED COAGULATION SYS | 1982-12-09 |
| NCAGE Code | 3H401 | ORTHO DIAGNOSTIC SYSTEMS INC |
| NCAGE Code | 56696 | ORTHO DIAGNOSTIC SYSTEMS INC |
| NCAGE Code | 61829 | ORTHO DIAGNOSTIC SYSTEMS INC |
| CAGE Code | 56696 | ORTHO DIAGNOSTIC SYSTEMS INC |
| CAGE Code | 61829 | ORTHO DIAGNOSTIC SYSTEMS INC |
| CAGE Code | 3H401 | ORTHO DIAGNOSTIC SYSTEMS INC |