VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
FDA premarket approval P100001/S010 · decided 2017-09-12
Approval details
- PMA number
- P100001
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2016-11-17
- Decision date
- 2017-09-12
- Days to decision
- 299 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for the migration of the VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
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 Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197) | Ortho Clinical Diagnostics | 2023-09-05 |
| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |