PMA P060012S007

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S007
Product code: LOM
Decision date: 2011-04-21
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A CHANGE OF TEST METHOD WITH A DIFFERENT ASSAY FOR DETERMINING ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN SPECIFIC ACTIVITY AND ALLOWING FOR USE OF HIGH TITER IGG IN IN PLACE OF EACH OTHER WHEN THEIR CONCENTRATIONS OVERLAP.

Current openFDA PMA Record#

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S007
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-04-21
Decision code: APPR
Date received: 2011-03-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE OF TEST METHOD WITH A DIFFERENT ASSAY FOR DETERMINING ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN SPECIFIC ACTIVITY AND ALLOWING FOR USE OF HIGH TITER IGG IN IN PLACE OF EACH OTHER WHEN THEIR CONCENTRATIONS OVERLAP.