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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.
 
Trade NameABBOTT AXSYM HAVAB-M 2.0
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitus a virus of igm class
Regulation Number866.3310
ApplicantABBOTT LABORATORIES
PMA NumberP790019
Supplement NumberS011
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
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.
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