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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
333 coney street
walpole, MA 02032-1516
PMA NumberP040004
Supplement NumberS004
Date Received03/09/2009
Decision Date04/09/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding advia centaur xp instrument to the intended use of theapproved device advia centaur hbc total assay. The device, as modified, will be marketed under the trade name advia centaur hbc total assay and is indicated for:the advia centaur hbc total assay is an in vitro diagnostic test for the qualitativedetermination of total antibodies to the core antigen of the hepatitis b virus (hbc total)in human serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur and advia centaur xp systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infectionand in the determination of the clinical status of hbv infected individuals in conjunctionwith other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differentialdiagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology isunknown.