Premarket Approval (PMA)

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 Name: ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
• Classification Name: assay,enzyme linked immunosorbent,hepatitis c virus
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
• PMA Number: P030056
• Date Received: 12/24/2003
• Decision Date: 12/22/2004
• 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