|Trade Name||ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Generic Name||antibody to hepatitis c virus|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the antimicrobial formulation to the axsym anti-hcv reagent sdb2 (specimen diluent). In addition, due to the reformulation of the sdb2, the instruction to use sterile water for tubing decontamination is no longer a required procedure and can be removed from the package insert labeling.