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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 NumberS003
Date Received08/11/2008
Decision Date07/31/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transition of the advia centaur anti-hbs assay to a new platform in the centaur family of instruments, the centaur cp. Advia centaur anti-hbs readypack reagents on the centaur cp analyzerthe 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 cp 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 serologicalmarkers for the laboratory diagnosis of hbv disease associated with hbv infection. Areactive assay result will allow a differential diagnosis in individuals displaying signs andsymptoms of hepatitis in whom etiology is unknown. Advia centaur anti-hbs quality controls on the centaur cp analyzerthe advia centaur anti-hbs quality controls are intended for in vitro diagnostic use in monitoring the performance of the anti-hbs assay on the advia centaur systems. The performance of the advia centaur anti-hbs quality controls has not been established with any other anti-hbs assay.