Ortho Clinical Diagnostics c/o Kuehne + Nagel

FDA Registration(s)#

PMA#

• AMERSHAM AFP

  1989-09-26

  ORTHO CLINICAL DIAGNOSTICS

• AMERSHAM AFP

  1986-03-17

  ORTHO CLINICAL DIAGNOSTICS

• AMERSHAM AFP

  1984-06-07

  ORTHO CLINICAL DIAGNOSTICS

PMN#

• VITROS Immunodiagnostic Products Syphilis Reagent Pack

  2024-08-28

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

  2024-05-08

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

  2023-09-05

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products CEA Reagent Pack

  2023-08-23

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

  2023-08-09

  Ortho Clinical Diagnostics

• VITROS Immuodiagnostic Products CA 125 II Reagent Pack

  2022-12-12

  Ortho Clinical Diagnostics

• VITROS AFP

  2022-06-15

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products CK-MB Reagent Pack

  2022-01-28

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

  2021-10-04

  Ortho Clinical Diagnostics

• VITROS BRAHMS PCT Reagent Pack And Calibrators

  2020-02-25

  Ortho Clinical Diagnostics

• VITROS Chemistry Products GLU Slides

  2017-09-18

  Ortho Clinical Diagnostics

• VITROS Chemistry Products HsCRP Reagent

  2017-07-14

  Ortho Clinical Diagnostics

• VITROS Immunodiagnostic Products Insulin Calibrators

  2017-05-16

  Ortho Clinical Diagnostics

• VITROS Chemistry Products Cl- Slides

  2016-12-16

  Ortho Clinical Diagnostics

• VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

  2015-09-24

  ORTHO CLINICAL DIAGNOSTICS

• VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I And II

  2015-06-04

  ORTHO CLINICAL DIAGNOSTICS

GUDID#

• VITROS - VITROS Immunodiagnostic Products CA 19-9TM Range Verifiers

  ORTHO CLINICAL DIAGNOSTICS

  2026-08-26

• VITROS - VITROS CA125 II Range Verifier

  ORTHO CLINICAL DIAGNOSTICS

  2026-07-21

• VITROS - VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2020-05-16

• VITROS - VITROS Immunodiagnostic Products BRAHMS PCT Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2020-05-16

• VITROS - VITROS Immunodiagnostic Products hs Troponin I Low Control

  ORTHO CLINICAL DIAGNOSTICS

  2025-12-30

• VITROS - VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2025-12-30

• VITROS - VITROS Immunodiagnostic Products hs Troponin Calibrators

  ORTHO CLINICAL DIAGNOSTICS

  2025-12-30

• VITROS - VITROS Immunodiagnostic Products RE Controls

  ORTHO CLINICAL DIAGNOSTICS

  2020-04-08

• VITROS - VITROS Immunodiagnostic Products NT proBNP Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2015-12-22

• VITROS - VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2015-12-22

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Calibrators

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Calibrators

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers

  ORTHO CLINICAL DIAGNOSTICS

  2025-05-20

• VITROS - VITROS Immunodiagnostic Products CK-MB Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2016-08-26

• VITROS - VITROS Immunodiagnostic Products Anti-HCV Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2014-10-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total N Controls

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2021-11-08

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2021-03-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2021-03-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2021-11-08

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls

  ORTHO CLINICAL DIAGNOSTICS

  2021-03-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2021-03-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2021-03-22

• VITROS - VITROS High Sample Diluent A

  ORTHO CLINICAL DIAGNOSTICS

  2023-05-12

• VITROS - VITROS High Sample Diluent B

  ORTHO CLINICAL DIAGNOSTICS

  2023-05-12

• VITROS - VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2024-01-20

• VITROS - VITROS Immunodiagnostic Products Intact PTH II Calibrators

  ORTHO CLINICAL DIAGNOSTICS

  2024-01-20

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Total B HCG II Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2024-09-18

• VITROS - VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Controls

  ORTHO CLINICAL DIAGNOSTICS

  2023-11-22

• VITROS - VITROS Immunodiagnostic Products Syphilis Reagent Pack

  ORTHO CLINICAL DIAGNOSTICS

  2024-09-18

• VITROS - VITROS Immunodiagnostic Products Syphilis Calibrator

  ORTHO CLINICAL DIAGNOSTICS

  2024-09-18

• VITROS - VITROS Immunodiagnostic Products Syphilis Controls

  ORTHO CLINICAL DIAGNOSTICS

  2024-09-18

• VITROS - VITROS Immunodiagnostic Products Insulin Calibrators

  ORTHO CLINICAL DIAGNOSTICS

  2018-01-12

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