|Trade Name||ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||ROCHE DIAGNOSTICS CORP.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of elecys coated microparticles.