Ortho-Clinical Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories14
Latest Approval2025-10-29
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | MMI | 2025-10-29 | View |
| 510(k) | DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | QVP | 2023-05-05 | View |
| 510(k) | DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QVP | 2023-05-05 | View |
| 510(k) | K210858 | VITROS Chemistry Products PHBR Slides | DLZ | 2021-08-13 | View |
| 510(k) | K191316 | VITROS XT Chemistry Products ALB-TP Slides | CIX | 2019-06-07 | View |
| 510(k) | K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | CIG | 2019-04-26 | View |
| 510(k) | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | CGA | 2019-04-03 | View |
| 510(k) | K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | CHH | 2019-03-27 | View |
| 510(k) | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | CDN | 2019-03-14 | View |
| PMA | P000014 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2018-12-17 | View |
| PMA | P030026 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2018-12-17 | View |
| 510(k) | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | JFY | 2018-10-30 | View |
| 510(k) | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | CGZ | 2018-10-30 | View |
| PMA | P090028 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2017-10-26 | View |
| PMA | P010021 | Assay, enzyme linked immunosorbent, hepatitis c virus | MZO | 2016-11-30 | View |
| 510(k) | K160495 | VITROS® Automation Solutions | KLI | 2016-10-18 | View |
| 510(k) | K161140 | VITROS Chemistry Products Calibrator Kit 3 | JIX | 2016-05-20 | View |
| PMA | P000044 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2016-03-30 | View |
No matching devices.