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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.
 
Trade NameETI-HA-IGMK PLUS KIT
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameradioimmunoassay kit
Regulation Number866.3310
ApplicantDIASORIN, INC.
PMA NumberP890014
Supplement NumberS008
Date Received09/07/2005
Decision Date12/14/2005
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change to the assay cutoff calculation that is designed to reduce the number of low level, non-clinically relevant positive results reported by the eti-ha-igmk plus assay.
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