PMA P110029S006

Device: ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S006
Product code: LOM
Decision date: 2012-11-19
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO A QUALITY CONTROL TEST METHOD FOR PURIFIED ANTIBODIES USED IN THE MANUFACTURE OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVECONFIRMATORY ASSAYS.

Current openFDA PMA Record#

Device: ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S006
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2012-11-19
Decision code: OK30
Date received: 2012-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO A QUALITY CONTROL TEST METHOD FOR PURIFIED ANTIBODIES USED IN THE MANUFACTURE OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVECONFIRMATORY ASSAYS.