PMA P050048S001

Device: BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT
Applicant: Bio-Rad Laboratories
PMA number: P050048
Supplement: S001
Product code: LOM
Decision date: 2008-07-17
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: ADDITION OF A NEW FILLING MACHINE FOR USE IN THE MANUFACTURE OF FILLED POSITIVE AND NEGATIVE CONTROL VIALS AND CALIBRATOR VIALS.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT
Applicant: Bio-Rad Laboratories
PMA number: P050048
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2008-07-17
Decision code: OK30
Date received: 2008-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW FILLING MACHINE FOR USE IN THE MANUFACTURE OF FILLED POSITIVE AND NEGATIVE CONTROL VIALS AND CALIBRATOR VIALS.