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Ortho-Clinical Diagnostics, Inc. FDA Approvals
0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack510(k)Oct 29, 2025Clinical Chemistry |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators510(k)May 5, 2023Microbiology |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator510(k)May 5, 2023Microbiology |
| VITROS Chemistry Products PHBR Slides510(k)Aug 13, 2021Clinical Toxicology |