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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
PMA NumberP030029
Supplement NumberS005
Date Received03/03/2009
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 anti-hbs ready pack reagents and calibrators. The device, as modified, will be marketed under the trade name advia centaur's) and advia centaur xp anti-hbs assay and is indicated for:advia centaur anti-hbs ready pack reagents and calibratorthe advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis b surface antigen in humanserum 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 ofsusceptibility to hepatitis b virus (hbv) infection in individuals prior to or followinghbv vaccination or where vaccination status is unknown. Assay results may be used withother hbv serological markers for the laboratory diagnosis of hbv disease associatedwith hbv infection. A reactive assay results will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur anti-hbs control materialfor monitoring the performance of the anti-hbs assay on the advia centaur and advia centaur xp systems.