|Trade Name||HAVAB-M EIA|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|Generic Name||hepatitis a test (antibody and igm antibody)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| 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.