PMA P060031

Device: BIO-RAD MONOLISA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S007
Product code: LOM
Decision date: 2013-12-12
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S007
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2013-12-12
Decision code: OK30
Date received: 2013-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.