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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.
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
PMA NumberP020011
Date Received03/18/2002
Decision Date11/07/2002
Product Code
MZP[ Registered Establishments with MZP ]
Docket Number 03M-0070
Notice Date 02/28/2003
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 versant hcv rna qualitative assay. The device is indicated for: the versant hcv rna qualitative assay is an in vitro nucleic acid amplification assay for the detection of hepatitis c virus (hcv) rna in human plasma (edta, sodium heparin, sodium citrate, and acd) or serum. The versant hcv rna qualitative assay is indicated for use with fresh or frozen specimens from the following populations: individuals with antibody evidence of hcv infection with evidence of liver disease, and individuals suspected to be actively infected with hcv with antibody evidence, and individuals at risk for hcv infection with antibodies to hcv. Detection of hcv rna is evidence of active hcv infection.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007