ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
FDA premarket approval P060007/S011 · decided 2011-03-30
Approval details
- PMA number
- P060007
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2011-03-01
- Decision date
- 2011-03-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- TEST METHOD CHANGE FOR QUANTITATING ANTI-D AND ANTI-Y MONOCLONAL ANTIBODIES WHICH ARE USED IN THE TESTING OF THE RECOMBINANT HBSAG SUBTYPE AD (CODE 98034) AND HBSAG SUBTYPE AY (CODE 98035) ANTIGENS USED IN THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAYS.
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