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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP030056
Date Received12/24/2003
Decision Date12/22/2004
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 05M-0478
Notice Date 11/28/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the advia centaur hcv. Hcv readypack reagents: 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 heparinized) using the advia centaur system. 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. Hcv quality control materials: 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.
Approval Order Approval Order
Supplements: S002 S003 S004 S005 S006 S007 
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