ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS
FDA premarket approval P110029/S021 · decided 2015-07-13
Approval details
- PMA number
- P110029
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2015-06-15
- Decision date
- 2015-07-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.
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