VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT
FDA premarket approval P000044/S024 · decided 2010-08-30
Approval details
- PMA number
- P000044
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2010-08-06
- Decision date
- 2010-08-30
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- USE OF AN ADDITIONAL SUPPLIER OF THE MATERIAL USED AS MOUSE MONOCLONAL ANTI-HBS ANTIBODY AND UPDATE OF THE RAW MATERIAL OF THE MOUSE MONOCLONAL ANTI-HBS ANTIBODY AND MANUFACTURING DOCUMENTATION OF THE VITROS HBSAG CONJUGATE REAGENT.
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