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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-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 NumberS011
Date Received11/13/2009
Decision Date01/12/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the sample stability claim for 48 hours at 2-8 degrees c to 6 days at 2-8 degrees c and modifications of the labeling to reflect the change.
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