|Trade Name||BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|
|Classification Name||assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus|
|Applicant||BAYER HEALTHCARE, LLC|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for transfer of the manufacture of the wash reagents (wash a and wash b) to a contract manufacturer. The number of bottles per lot will be increased for both wash a and wash b.