|Trade Name||ABBOTT AXSYM HAVAB 2.0|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|Generic Name||antibody to hepatitis a virus 125i (human)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the abbott axsym havab 2. 0. The device, as modified, will be marketed under the trade name abbott axsym havab 2. 0 and is indicated for the qualitative detection of total antibody to hepatitis a virus (anti-hav) in human serum or plasma. A test for anti-hav is indicated as an aid in the diagnosis of previous or ongoing hepatitis a viral infection or in the identification of hav-susceptible individuals for vaccination.