|Trade Name||DIASORIN ETI-MAK-2 PLUS ASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||eia for hepatitis surface ag (hbs ag)|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a revision in the assay package insert that incorporates a change in the interpretation algorithm for repeat testing results that make it the same as the interpretation for initial testing. "the user should apply the same interpretation of results (i. E. Reactive samples should have an absorbance value greater than 90% of the cutoff) when initial testing for some samples and repeat testing for other samples are performed on the same plate. ".