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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitis a virus 125i (human)
Regulation Number866.3310
PMA NumberP780012
Supplement NumberS009
Date Received06/09/2000
Decision Date02/02/2004
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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.