|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||ETI-MAK-2 PLUS|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||special (immediate track)|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for manufacturing changes in the way the positive control is made.