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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 NameDIASORIN ETI-AB-HAVK PLUS ASSAY
Classification Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDIASORIN, INC.
PMA NumberP890019
Supplement NumberS009
Date Received01/30/2004
Decision Date02/20/2004
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the package insert: the supplement contains a revision in the assay package insert that states "all lots of incubation buffer are interchangeable between eti-ebk plus, eti-ab-ebk plus, eti-ab-havk plus. ".
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