PMA P780012S012

Device: ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S012
Product code: LOL
Decision date: 2002-09-05
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.

Current openFDA PMA Record#

Device: ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S012
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2002-09-05
Decision code: OK30
Date received: 2001-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.