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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceBIO-RAD MONOLISA ANTI-HBC IGM EIA
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBio-Rad Laboratories, Inc.
6565 185TH AVE., N.E.
REDMOND, WA 98052
PMA NumberP060034
Supplement NumberS002
Date Received09/30/2008
Decision Date02/20/2009
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.
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