VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
FDA premarket approval P090028/S010 · decided 2017-09-12
Approval details
- PMA number
- P090028
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2016-12-02
- Decision date
- 2017-09-12
- Days to decision
- 284 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 HBeAg Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
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