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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMONOLISA 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
Date Received12/05/2005
Decision Date08/25/2006
Product Code LOM 
Docket Number 07M-0151
Notice Date 04/19/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MONOLISA ANTI-HBS EIA AND THE MONOLISA ANTI-HBS CALIBRATOR KIT. THE DEVICES ARE INDICATED FOR: THE MONOLISA ANTI-HBS EIA IS A QUALITATIVE AND QUANTITATIVE ENZYME IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA OR CITRATED PLASMA. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO 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 CALIBRATOR KIT IS INTENDED FOR QUANTITATIVE DETERMINATION OF ANTI-HBS IN HUMAN SERUM AND EDTA OR CITRATED PLASMA. THE MONOLISA ANTI-HBS CALIBRATOR KIT IS TO BE USED ONLY WITH THE MONOLISA ANTI-HBS EIA.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 
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