|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-EBK PLUS|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||eia for antibody to hepatitis be antigen|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the quality control test of an incoming raw material used in the preparation of coated strips of the eti-ab-ebk plus which is an in vitro enzyme immunoassay intended for use in the qualitative determination of total antibodies to hepatitis b e antigen in human serum or plasma.