VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
FDA premarket approval P010021/S033 · decided 2020-08-07
Approval details
- PMA number
- P010021
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2020-07-20
- Decision date
- 2020-08-07
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Amendment of the assay specific release for sale limits used in the release testing of Immunodiagnostic Products, VITROS Anti-HCV reagent pack and calibrators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (DEN210038) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| VITROS Chemistry Products PHBR Slides (K210858) | Ortho-Clinical Diagnostics, Inc. | 2021-08-13 |
| VITROS XT Chemistry Products ALB-TP Slides (K191316) | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 |
| VITROS XT Chemistry Products TBIL-ALKP Slides (K190807) | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 |
| VITROS XT Chemistry Products GLU-Ca Slides (K190520) | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| VITROS XT Chemistry Products TRIG-CHOL Slides (K190490) | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 |