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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-HBS EIA
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBIO-RAD LABORATORIES
6565 185TH AVE, NE
REDMOND, WA 98052
PMA NumberP050048
Supplement NumberS009
Date Received11/13/2013
Decision Date12/12/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
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