PMA P050049S002

Device: ABBOTT AXSYM HBSAG
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S002
Product code: LOM
Decision date: 2007-12-19
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS THAT CLARIFIES THE MEANING OF THE FINAL INTERPRETATION REPEAT REACTIVE, NONCONFORMING FOR HBSAG IN THE AXSYM HBSAG CONFIRMATORY PACKAGE INSERT. ALSO, CHANGES TO THE AXSYM HBSAG PACKAGE INSERT TO ALIGN WITH THE REMOVAL OF THE TERM "REPEAT REACTIVE" FROM THE INTERPRETATION OF RESULTS FOR THE AXSYM HBSAG CONFIRMATORY ASSAYS.

Current openFDA PMA Record#

Device: ABBOTT AXSYM HBSAG
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S002
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2007-12-19
Decision code: APPR
Date received: 2007-12-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS THAT CLARIFIES THE MEANING OF THE FINAL INTERPRETATION REPEAT REACTIVE, NONCONFORMING FOR HBSAG IN THE AXSYM HBSAG CONFIRMATORY PACKAGE INSERT. ALSO, CHANGES TO THE AXSYM HBSAG PACKAGE INSERT TO ALIGN WITH THE REMOVAL OF THE TERM "REPEAT REACTIVE" FROM THE INTERPRETATION OF RESULTS FOR THE AXSYM HBSAG CONFIRMATORY ASSAYS.