|Trade Name||DIASORIN ETI-AB-AUK PLUS ASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||eia for antibody to hepatitis b surface antigen|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the march 30, 2001 approval order for p990042.