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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 Nameassay,enzyme linked immunosorbent,hepatitis c virus
PMA NumberP030056
Supplement NumberS004
Date Received03/09/2009
Decision Date04/09/2009
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding advia centaur xp instrument to the intended use of the approved device advia centaur hcv assay. The device, as modified, will be marketed under the trade name advia centaur hcv assay and is indicated for: advia centaur hcv assay: the advia centaur hcv assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human serum and plasma (edta, lithium or sodium heparin) using the advia centaur and advia centaur xp systems. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection. Advia centaur hcv quality controls: for in vitro diagnostic use in monitoring the performance of the hcv assay on the advia centaur systems. The performance of the hcv quality control material has not been established with any other anti-hcv assays.