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