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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,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
PMA NumberP020011
Supplement NumberS005
Date Received04/05/2012
Decision Date06/25/2012
Product Code
MZP[ Registered Establishments with MZP ]
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 a device name change. The device, as modified, will be marketed under the trade name versant hcv rna qualitative assay and aptima hcv rna qualitative assay and is indicated for the detection of hepatitis c virus (hcv) rna in human plasma (edta, sodium heparin, sodium citrate, and acd) or serum.