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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-EBK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for antibody to hepatitis be antigen
ApplicantDIASORIN, INC.
PMA NumberP990041
Supplement NumberS004
Date Received01/30/2004
Decision Date02/20/2004
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
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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