BIO-RAD MONOLISA ANTI-HBC EIA

FDA Premarket Approval P060031 S007

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

Change to add test samples as an additional acceptance criterion to the final kit release quality control testing procedure.

• Device: BIO-RAD MONOLISA ANTI-HBC EIA
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: Bio-Rad Laboratories, Inc.
• Date Received: 2013-11-13
• Decision Date: 2013-12-12
• PMA: P060031
• Supplement: S007
• 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
P060031		Original Filing
S007	2013-11-13	30-day Notice
S006	2012-10-19	30-day Notice
S005	2011-03-31	30-day Notice
S004	2010-06-17	Normal 180 Day Track No User Fee
S003	2009-09-28	Normal 180 Day Track
S002	2009-02-12	Special (immediate Track)
S001	2008-09-22	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00847865013116	P060031	000
00847865013109	P060031	000
00847865013093	P060031	000
00847865013086	P060031	000
00847865013079	P060031	000
00847865011372	P060031	000