Ortho Diagnostic Systems, Inc.
FDA 510(k) medical device clearances.
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
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