|Trade Name||ABBOTT ARCHITECT ANTI-HCV|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||ABBOTT LABORATORIES 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 delkenheim, germany for the manufacture of architect anti-hcv reagent kit, architect anti-hcv calibrator, and architect anti-hcv controls.