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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 NumberS004
Date Received09/28/2009
Decision Date04/25/2011
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 USE OF THE MONOLISA ANTI-HBS EIA ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM, ADDING LITHIUM HEPARIN AND SODIUM HEPARIN TO THE LIST OF ACCEPTABLE PLASMA SPECIMEN TYPES, A CHANGE IN THE DYE COLOR IN THE CUTOFF CALIBRATOR, REVISION TO THE SPECIMEN STORAGE REQUIREMENTS, AND MODIFICATION OF THE STORAGE INSTRUCTIONS FOR THE WORKING CONJUGATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MONOLISA ANTI-HBS EIA AND IS INDICATED FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA, HEPARIN, OR CITRATED PLASMA. THE ASSAY RESULTS MAY BE USED AS AN AIDE IN THE DETERMINATION OF SUSCEPTIBILITY OF HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE MONOLISA ANTI-HBS EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN.
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