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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)
Regulation Number866.3310
PMA NumberP890019
Supplement NumberS005
Date Received11/24/1997
Decision Date09/22/1998
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product 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.