|Trade Name||ABBOTT IMX(R) HAVAB(R)-M|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|Generic Name||antibody to hepatitus a virus of igm class|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the specifications for the positive control sample to standard ratio from 0. 90-1. 15 to 0. 85-1. 15, and a change in the evaluation of the hepatitis a virus solution and the havab(r)-m eia conjugate from a sample to standard ratio to a sample to target ratio.