|Trade Name||DIASORIN ETI-HA-IGMK PLUS|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|Generic Name||radioimmunoassay kit|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the enzyme tracer and tracer diluent from a igg (sheep) anti-hav-hrp to a fab anti-hav (mab)-hrp; a chang ein the positive control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a calibrator reagent. The device, as modified, will be marketed under the trade name diasorin eti-ha-igmk plus and is intended for use in the qualitative determination of igm antibodies to hepatitis a virus (igm anti-hav) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis a virus infection.