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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 Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Abbott Laboratories
d-49c, building ap6c
100 abbott park road
abbott park north, IL 60064-3500
PMA NumberP790019
Supplement NumberS016
Date Received10/07/2002
Decision Date11/06/2002
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to 1) replace lyophilized goat anti-human igm purchased from litton bionetics with non-lyophilized goat anti-human igm purchased from jackson immuno research. 2) replace rheophoresis testing for goat anti-human igm (antibody) identity/specificity with immunoelectro-phoresis (iep) testing. 3) replace havab-m ria (radioimmunoassay) antibody bead coat efficacy testing with small-scale antibody dilution factor determination and confirmation testing using havab-m eia (enzyme immunoassay) to establish the optimal dilution factor of the goat anti-human igm antibody to be used for full-scale production bead coating.