|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|
|Generic 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 - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modification to the purification and desalting processes for two classes of oligonucleotides (rxl intermediates and ppos), which are components of some reagents of the device.