|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|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling modifications that correct the error in the axsym anti-hcv package insert (list number 5c36) under reatents section. The minimum concentration of ?% solids? for the recombinant hcv antigen coated microparticles of the axsym anti-hcv reagent pack is being changed from ?0. 05%? to ?0. 04%? to align with current manufacturing process.