PMA P060031S001

Device: BIO-RAD MONOLOSA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S001
Product code: LOM
Decision date: 2008-10-09
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: ADDING A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT.

Current openFDA PMA Record#

Device: BIO-RAD MONOLOSA ANTI-HBC EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060031
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2008-10-09
Decision code: OK30
Date received: 2008-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDING A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT.