Ortho Diagnostic Systems, Inc.
Ortho Diagnostic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1981, most recent 1997.
Top product codes for Ortho Diagnostic Systems, Inc.
Recent clearances by Ortho Diagnostic Systems, Inc.
1–100 of 126- K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
- K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
- K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
- K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
- K955638 — SYNTHAFAX APTT REAGENT
- K953981 — SYNTHASIL APTT REAGENT
- K941192 — ORTHO ALT MICROWELL TEST SYSTEM
- K940209 — ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
- K932530 — ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
- K932531 — ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
- K932532 — ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
- K935748 — ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
- K941713 — ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
- K931443 — ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
- K930002 — ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
- K930020 — ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
- K925604 — ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
- K925208 — ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
- K914188 — KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
- K921321 — ORTHO CHLAMYDIA ANTIGEN ELISA TEST
- K920412 — MODIFIED ORTHO EBV VCA-IGG ELISA
- K915551 — ORTHO HSV ANTIGEN ELISA TEST
- K911569 — EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
- K911570 — EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
- K911571 — EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
- K904253 — ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
- K910668 — ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
- K903132 — ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
- K905077 — ORTHO CMV-M ANTIBODY ELISA TEST
- K905078 — ORTHO CMV-G ANTIBODY ELISA TEST
- K905079 — ORTHO RUBELLA-M ANTIBODY ELISA TEST
- K902210 — ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
- K901327 — ORTHO CORRECTION REAGENTS
- K901120 — KOAGULAB 60-S COAGULATION SYSTEM
- K901233 — ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
- K900395 — ORTHOKROME* FACTOR VIII
- K900396 — ORTHOKROME* HEPARIN
- K900397 — ORTHOKROME* ANTIPLASMIN
- K900398 — ORTHOKROME* PROTEIN C
- K900399 — ORTHOKROME* PLASMINOGEN
- K900400 — ORTHOKROME* ANTITHROMBIN
- K896479 — ORTHO* RUBELLA-G ANTIBODY ELISA TEST
- K894420 — ORTHO RESULT PLUS/PREGNANCY
- K891382 — ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
- K883937 — ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
- K885035 — KOAGULAB* 32-S COAGULATION SYSTEM
- K884617 — ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
- K883935 — ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
- K883940 — ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
- K883938 — ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
- K883939 — ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
- K883688 — ORTHO FACTOR XII DEFICIENT PLASMA
- K883689 — ORTHO OWREN'S BUFFER
- K883690 — ORTHO FACTOR X DEFICIENT PLASMA
- K883691 — ORTHO FACTOR XI DEFICIENT PLASMA
- K883692 — ORTHO FACTOR VII DEFICIENT PLASMA
- K883936 — ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
- K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
- K872541 — ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
- K881500 — ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
- K875162 — ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
- K872628 — GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
- K872730 — RESULT PLUS/HCG PREGNANCY TEST
- K871552 — ORTHO* SPECIMEN COLLECTION CYTOBRUSH
- K863490 — ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
- K862537 — KOAGULAB* M COAGULATION SYSTEM
- K854488 — ORTHO HSV ANTIGEN ELISA TEST
- K853738 — ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
- K853328 — KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
- K852360 — ORTHO DNA PROBE HSV CONFIRMATION TEST
- K853500 — ORTHO VIRAL TRANSPORT
- K852834 — ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
- K851641 — THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
- K842216 — CULTURESET HSV ISOLATION & ID SYS
- K843535 — ORTHO BRAIN THROMBOPLASTIN DILUENT
- K842047 — ORTHO* RSV ANTIGEN ELISA TEST SYS
- K841527 — ORTHO RESPIRATORY SYNCYTIAL VIRUS-
- K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT.
- K833636 — ORTHO* SERUM ELISA TEST SYSTEM
- K841557 — ORTHO MICROWELL READER
- K841200 — RUBELLA IGG ANTIBODY ELISA TEST SYS
- K834449 — HSV ANTIGEN ELISA KIT
- K834064 — ORTHO BI-LEVEL RECEPTOR CONTROL
- K833834 — ORTHO BACTERIURIA DETECTION SYS
- K833137 — ORTHO B-HCG SLIDE TEST FOR PREGNANCY
- K833618 — ORTHO ELT-8/DS HEMATOLOGY ANALYZER
- K832947 — ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO
- K831670 — ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
- K832225 — ORTHO ABNORMAL COAGULATION LEVEL I/II
- K831271 — ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
- K831500 — TRI-LEVEL TDM CONTROL & I II III
- K822342 — ORTHO RUBELLA ELISA TEST SYSTEM
- K823590 — MANUALISA MICROTITRATION PLATE READER
- K823490 — ORTHO BI-LEVEL ASSAYED LIPID PROFILE
Data sourced from openFDA. This site is unofficial and independent of the FDA.