PMA P060009S005

Device: AXSYM CORE-M 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060009
Supplement: S005
Product code: LOM
Decision date: 2011-04-04
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGES TO REPLACE REAGENTS FOR IN- PROCESS TESTING OF THE HBV CORE ANTIGEN (ANTI-HBC) SPECIFIC ACTIVITY AND TO ALLOW THE USE OF TWO ALTERNATIVE PRECURSORS FOR MANUFACTURING OF THE PURIFIED FILTERED HBC IGG WITHIN THE ABBOTT PARK, ILLINOIS MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: AXSYM CORE-M 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060009
Supplement: S005
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-04-04
Decision code: OK30
Date received: 2011-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO REPLACE REAGENTS FOR IN- PROCESS TESTING OF THE HBV CORE ANTIGEN (ANTI-HBC) SPECIFIC ACTIVITY AND TO ALLOW THE USE OF TWO ALTERNATIVE PRECURSORS FOR MANUFACTURING OF THE PURIFIED FILTERED HBC IGG WITHIN THE ABBOTT PARK, ILLINOIS MANUFACTURING FACILITY.