VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR
FDA premarket approval P000044/S026 · decided 2011-05-11
Approval details
- PMA number
- P000044
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2011-04-28
- Decision date
- 2011-05-11
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE IN THE PROCESS OF PREPARING ANTIFOAM SOLUTION AND THE STORAGE CONDITIONS OF PREPARED ANTIFOAM SOLUTION.
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 |