PMA P060007S011

Device: ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S011
Product code: LOM
Decision date: 2011-03-30
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order 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.

Current openFDA PMA Record

Device: ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S011
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-03-30
Decision code: OK30
Date received: 2011-03-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.