|Trade Name||ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||ABBOTT LABORATORIES INC|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a test method to detect changes between the bulk and the master lot (customer release) testing stages.