VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
FDA premarket approval P100001/S017 · decided 2023-01-24
Approval details
- PMA number
- P100001
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2022-09-30
- Decision date
- 2023-01-24
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for revisions to the package insert to include information on biotin interference.
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|---|---|---|
| VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
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| 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 |