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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP030029
Date Received07/02/2003
Decision Date05/14/2004
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 05M-0025
Notice Date 01/21/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S011 
S012 S013 
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