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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 Nameradioimmunoassay kit
Regulation Number866.3310
PMA NumberP890014
Supplement NumberS002
Date Received11/24/1997
Decision Date09/16/1998
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 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.