ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS
FDA premarket approval P000014/S027 · decided 2014-03-10
Approval details
- PMA number
- P000014
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2014-02-14
- Decision date
- 2014-03-10
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- ADDITION OF NEGATIVE SAMPLES IN THE FINAL RELEASE QC TEST, AND AN ADDITION OF THE RAW MATERIAL COMBINATION TEST IN THE MANUFACTURE OF THE CONJUGATE REAGENT.
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