BIO-RAD MONOLISA ANTI-HBC IGM EIA

FDA Premarket Approval P060034 S002

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

Approval for an amendment to the package insert with the addition of the statement that allows storage of the working conjugate solution at room temperature for 30 hours, up to 10 cycles of 3 hours at room temperature allowed for the device.

• 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: 2008-09-30
• Decision Date: 2009-02-20
• PMA: P060034
• Supplement: S002
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• 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