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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-COREK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for total antibodies to hepatitis b core antigen
ApplicantDIASORIN, INC.
PMA NumberP990045
Supplement NumberS016
Date Received12/27/2013
Decision Date01/10/2014
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of hbsag positive samples.
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