|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 Name||AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS|
|Classification Name||hepatitis a test (antibody and igm antibody)|
|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 an igg (human) anti-hav-hrp to a fab anti-hav (mab)-hrp; a change in the positive control and negative control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a calibrator reagent. The device, as modified, will be marketed under the trade name diasorin eti-ab-havk plus and is intended for the qualitative determination of total antiboides to hepatitis a virus (anti-hav) in human serum or plasma. This assay is indicated for use as an aid in the dignosis of current or previous hepatitis a virus infection and as an aid in the diagnosis of current or previous hepatitis a virus infection and as an aid in the identification of hav-susceptible individuals for vaccination.