|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of the final packaging process to a different line within the mannheim, germany site and to change the box and spacer element size, main and side label size and label layout.