VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
FDA premarket approval P000014/S023 · decided 2011-03-10
Approval details
- PMA number
- P000014
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2011-02-14
- Decision date
- 2011-03-10
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE TO MANUFACTURE AND STORE THE ANTIFOAM SOLUTION USED IN VITROS ANTI-HBS CONJUGATE REAGENT.
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