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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameADVIA CENTAUR ANTI-HBS (AHBS)
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS CORP.
PMA NumberP030029
Supplement NumberS004
Date Received09/18/2008
Decision Date06/10/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma to the intended use. The device, as modified, will be marketed under the trade name advia centaur® and advia centaur® xp anti-hbs assay and is indicated for: the advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma (edta or heparinized) using the advia centaur and advia centaur xp systems. 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 i hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
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