|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.|
|Trade Name||VERSANT HCV RNA QUALITATIVE ASSAY|
|Classification Name||assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| 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.