BIO-RAD MONOLISA ANTI-HBC IGM EIA

FDA Premarket Approval P060034 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Addition of a new filling machine for use in the manufacturing of the positive and negative control vials and the calibrator vial in the kit.

• Device: BIO-RAD MONOLISA ANTI-HBC IGM EIA
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: Bio-Rad Laboratories, Inc.
• Date Received: 2008-09-22
• Decision Date: 2008-10-09
• PMA: P060034
• Supplement: S001
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Bio-Rad Laboratories, Inc. 6565 185th Ave., N.e. redmond, WA 98052

Supplemental Filings

Supplement Number	Date	Supplement Type
P060034		Original Filing
S008	2014-02-26	30-day Notice
S007	2013-11-13	30-day Notice
S006	2012-10-19	30-day Notice
S005	2010-06-17	Normal 180 Day Track No User Fee
S004	2009-09-25	Normal 180 Day Track
S003
S002	2008-09-30	Real-time Process
S001	2008-09-22	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00847865013178	P060034	000
00847865013161	P060034	000
00847865013154	P060034	000
00847865013147	P060034	000
00847865013130	P060034	000
00847865013123	P060034	000
00847865011365	P060034	000