PMA P050049S008

Device: ABBOTT AXSYM HBSAG
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S008
Product code: LOM
Decision date: 2011-11-14
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A CHANGE TO A SUPPLIER FOR AN INCOMING RAW MATERIAL, NONFAT DRY MILK (NFDM) THAT IS A COMPONENT OF THE AXSYM HBSAG CONJUGATE DILUENT IN THE AXSYM HBSAG REAGENT PACK IN THE AXSYM HBSAG ASSAY.

Current openFDA PMA Record#

Device: ABBOTT AXSYM HBSAG
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S008
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-11-14
Decision code: APPR
Date received: 2011-08-01
Supplement type: 135 Review Track For 30-Day Notice
Approval order statement: APPROVAL FOR A CHANGE TO A SUPPLIER FOR AN INCOMING RAW MATERIAL, NONFAT DRY MILK (NFDM) THAT IS A COMPONENT OF THE AXSYM HBSAG CONJUGATE DILUENT IN THE AXSYM HBSAG REAGENT PACK IN THE AXSYM HBSAG ASSAY.