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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-AB-AUK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for antibody to hepatitis b surface antigen
ApplicantDIASORIN S.P.A.
PMA NumberP990042
Supplement NumberS001
Date Received09/07/2001
Decision Date02/04/2002
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification to the assay cutoff from 15 miu/ml to 10 miu/ml.
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