MONOLISA ANTI-HBC IGM EIA

FDA Premarket Approval P060034 S005

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 a manufacturing site located at bio-rad laboratories in woodinville, washington.

DeviceMONOLISA ANTI-HBC IGM EIA
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantBio-Rad Laboratories, Inc.
Date Received2010-06-17
Decision Date2010-11-23
PMAP060034
SupplementS005
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bio-Rad Laboratories, Inc. 6565 185th Ave., N.e. redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P060034Original 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 IDPMASupp
00847865013178 P060034 000
00847865013161 P060034 000
00847865013154 P060034 000
00847865013147 P060034 000
00847865013130 P060034 000
00847865013123 P060034 000
00847865011365 P060034 000

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