|Trade Name||VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY|
|Classification Name||assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change of location for a qc lab to segregate the pre- and post-amplification steps into separate rooms.