|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||DIASORIN ETI-AB-HAVK PLUS ASSAY|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the package insert: the supplement contains a revision in the assay package insert that states "all lots of incubation buffer are interchangeable between eti-ebk plus, eti-ab-ebk plus, eti-ab-havk plus. ".