|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||ABBOTT AXSYM ANTI-HCV|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Generic Name||antibody to hepatitis c virus|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in the manufacturing process.