ORTHO-CLINICAL DIAGNOSTICS, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

  2020-10-22

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

  2020-08-07

  Ortho-Clinical Diagnostics, Inc.

• VITROS HBeAg

  2019-06-19

  Ortho-Clinical Diagnostics, Inc.

• VITROS Anti-HBc IgM

  2019-06-19

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

  2019-06-19

  Ortho-Clinical Diagnostics, Inc.

• VITROS HBsAg

  2019-06-19

  Ortho-Clinical Diagnostics, Inc.

• VITROS Anti-HBs

  2019-06-19

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

  2018-12-17

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

  2018-12-17

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

  2018-12-17

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

  2018-12-17

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

  2018-12-17

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

  2018-07-02

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

  2018-02-23

  Ortho-Clinical Diagnostics, Inc.

• HBeAg Reagent Pack and Calibrator

  2018-02-16

  Ortho-Clinical Diagnostics, Inc.

• Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator

  2017-11-09

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator

  2017-10-26

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

  2017-09-12

  Ortho-Clinical Diagnostics, Inc.

• VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator

  2017-06-27

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

  2016-11-30

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

  2016-03-30

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

  2015-12-16

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR

  2015-11-20

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR

  2015-11-03

  Ortho-Clinical Diagnostics, Inc.

• VITROS HBSAG ASSAY

  2015-09-08

  Ortho-Clinical Diagnostics, Inc.

• VITROS ANTI-HBC IGM ASSAY

  2015-09-08

  Ortho-Clinical Diagnostics, Inc.

• VITROS ANTI-HCV ASSAY

  2015-09-08

  Ortho-Clinical Diagnostics, Inc.

• VITROS ANTI-HBS ASSAY

  2015-09-08

  Ortho-Clinical Diagnostics, Inc.

• VITROS HBEAG ASSAY

  2015-09-08

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR

  2015-07-23

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

  2015-07-23

  Ortho-Clinical Diagnostics, Inc.

165 records. Showing 1-40. Next

PMN#

• VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

  2025-10-29

  Ortho-Clinical Diagnostics, Inc.

• System, Test, Automated Blood Grouping And Antibody

  2022-06-24

  Ortho-Clinical Diagnostics, Inc.

• VITROS Chemistry Products PHBR Slides

  2021-08-13

  Ortho-Clinical Diagnostics, Inc.

• System, Test, Automated Blood Grouping And Antibody

  2021-05-13

  Ortho-Clinical Diagnostics, Inc.

• System, Test, Automated Blood Grouping And Antibody

  2021-05-13

  Ortho-Clinical Diagnostics, Inc.

• System, Test, Automated Blood Grouping And Antibody

  2021-03-10

  Ortho-Clinical Diagnostics, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2019-12-17

  Ortho-Clinical Diagnostics, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2019-07-09

  Ortho-Clinical Diagnostics, Inc.

• VITROS XT Chemistry Products ALB-TP Slides

  2019-06-07

  Ortho-Clinical Diagnostics, Inc.

• VITROS XT Chemistry Products TBIL-ALKP Slides

  2019-04-26

  Ortho-Clinical Diagnostics, Inc.

• VITROS XT Chemistry Products GLU-Ca Slides

  2019-04-03

  Ortho-Clinical Diagnostics, Inc.

• VITROS XT Chemistry Products TRIG-CHOL Slides

  2019-03-27

  Ortho-Clinical Diagnostics, Inc.

• VITROS XT Chemistry Products UREA-CREA Slides

  2019-03-14

  Ortho-Clinical Diagnostics, Inc.

• VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

  2018-10-30

  Ortho-Clinical Diagnostics, Inc.

• VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

  2018-10-30

  Ortho-Clinical Diagnostics, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2016-10-21

  Ortho-Clinical Diagnostics, Inc.

• VITROS® Automation Solutions

  2016-10-18

  Ortho-Clinical Diagnostics, Inc.

• VITROS Chemistry Products Calibrator Kit 3

  2016-05-20

  ORTHO-CLINICAL DIAGNOSTICS, INC.

• Automated Blood Grouping And Antibody Test Systems

  2015-08-14

  Ortho-Clinical Diagnostics, Inc.

• Automated Cell-washing Centrifuge For Immune-hematology

  2013-08-09

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS TRIG SLIDES

  2013-05-31

  Ortho-Clinical Diagnostics, Inc.

• Automated Bloodborne Pathogen Test Equipment

  2013-05-23

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

  2013-05-15

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS

  2013-02-15

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

  2012-10-24

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS DHDL SLIDES

  2012-09-07

  Ortho-Clinical Diagnostics, Inc.

• Automated Bloodborne Pathogen Test Equipment

  2012-03-15

  Ortho-Clinical Diagnostics, Inc.

• Automated Bloodborne Pathogen Test Equipment

  2011-06-28

  Ortho-Clinical Diagnostics, Inc.

• Automated Bloodborne Pathogen Test Equipment

  2010-10-28

  Ortho-Clinical Diagnostics, Inc.

• 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

  2010-07-22

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;

  2010-04-15

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927

  2009-09-03

  Ortho-Clinical Diagnostics, Inc.

• Automated Bloodborne Pathogen Test Equipment

  2009-05-27

  Ortho-Clinical Diagnostics, Inc.

• ORTHO T. CRUZI ELISA TEST SYSTEM

  2009-04-15

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

  2009-02-27

  Ortho-Clinical Diagnostics, Inc.

• VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM

  2008-10-23

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

  2008-08-21

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

  2008-06-30

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

  2007-12-07

  Ortho-Clinical Diagnostics, Inc.

• VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

  2007-09-24

  Ortho-Clinical Diagnostics, Inc.

138 records. Showing 1-40. Next

GUDID#

• VITROS - VITROS Chemistry Products URIC Slides

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2020-05-16

• ORTHO - ORTHO VISION™ Max Analyzer (MTS)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2017-03-23

• ORTHO - ORTHO VISION™ Analyzer (MTS)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2016-08-24

• BIOCLONE - ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-C (ANTI-RH2) (MONOCLONAL) BIOCLONE 1X5ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-SMALL C (ANTI-RH4) (MONOCLONAL) BIOCLONE 1X5ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - ANTI-D BIOCLONE 15X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - ORTHO® Pooled Screening Cells

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• SURGISCREEN - Surgiscreen®

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• AFFIRMAGEN - 0.8% Affirmagen® (Pooled Cells)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• AFFIRMAGEN - Affirmagen® (Pooled Cells)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• AFFIRMAGEN - 0.8% Affirmagen® 3 (Pooled Cells)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - Ortho® A2 Cells (Pooled Cells)

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - ORTHO Ficin Panel System RESOLVE PANEL C Ficin Treated and Untreated 22X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - RESOLVE PANEL A 11X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - RESOLVE PANEL B 11X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• SELECTOGEN - SELECTOGEN 2X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - Anti-Jkb (Monoclonal) BioClone

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - ORTHO® HCV Version 3.0 ELISA Test System

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - ORTHO® HCV Version 3.0 ELISA Test System

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - Anti-A BIOCLONE 3x10ml

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - Anti-B BIOCLONE 3x10ml

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• BIOCLONE - Anti-D BIOCLONE 3x10ml

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - 0.8% POOLED SCREENING CELLS 2X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• SELECTOGEN - 0.8% SELECTOGEN 2X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• SURGISCREEN - 0.8% SURGISCREEN 3X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - 0.8% RESOLVE PANEL A 11X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - 0.8% RESOLVE PANEL B 11X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• RESOLVE - 0.8% RESOLVE PANEL C 22X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• VITROS - VITROS Chemistry Products ALB Slides

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2016-08-23

• VITROS - VITROS Chemistry Products ALB Slides

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2016-08-23

• VITROS - VITROS XT 7600 Integrated System - Certified

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2025-05-21

• BIOCLONE - ANTI-LEB (LE2) (MURINE MONOCLONAL) BIOCLONE 2.0

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - ANTI-D (Anti-Rho) for Slide and Modified Tube Tests 15X10ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

• ORTHO - ANTI-FYA (ANTI-DUFFY A) 1X3ML

  ORTHO-CLINICAL DIAGNOSTICS, INC.

  2014-10-22

200 records. Showing 1-40. Next