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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 NumberS004
Date Received09/25/2009
Decision Date08/02/2010
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR EXPANDING THE INTENDED USE TO INCLUDE USE WITH THE EVOLISAUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMEMONOLISA ANTI-HBC IGM EIA AND IS INDICATED FOR USE IN THE QUALITATIVE DETECTION OF IGMANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUMEDTA, SODIUM CITRATE, ACD [ACID CITRATE DEXTROSE], LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THE MONOLISA ANTI-HBC IGM IS INTENDED FORMANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OFIGM ANTIBODIES TO HEPATITIS B VIRUS.
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