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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 IMX(R) HAVAB(R)-M
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 NumberS008
Date Received01/31/1997
Decision Date03/27/1997
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the reference panel, to remove the igm anti-hbc positive plasma and the rheumatoid factor positive plasma mixed with high titer anti-hav igg positive plasma.
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