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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.
 
DeviceADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 Coney Street
Walpole, MA 02032
PMA NumberP030029
Date Received07/02/2003
Decision Date05/14/2004
Withdrawal Date 05/24/2016
Product Code LOM 
Docket Number 05M-0025
Notice Date 01/21/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND ADVIA CENTAUR ANTI-HBS READYPACK CALIBRATORS. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. 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 IN UNKNOWN.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 
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