VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
FDA premarket approval P000044 · decided 2001-04-27
Approval details
- PMA number
- P000044
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2000-11-01
- Decision date
- 2001-04-27
- Days to decision
- 177 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNODIAGNOSTIC PRODUCTS CALIBRATOR. THE VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY
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 |