|Trade Name||COBAS AMPLICOR HCV TEST VERSION 2.0|
|Classification Name||assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus|
|Applicant||ROCHE MOLECULAR SYSTEMS, INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located in somerville, new jersey for oligonucleotide and enzyme manufacturing.