VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR
FDA premarket approval P000014/S025 · decided 2012-03-13
Approval details
- PMA number
- P000014
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2012-02-15
- Decision date
- 2012-03-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- 1) CHANGING THE TIMINGS OF THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT DESCRIBED AS THE SINGLE-TEST; AND 2) REDUCING THE NUMBER OF THE ASSAYS IN THE MGCC RELEASE TEST.
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