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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-EBK PLUS KIT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for hepatitis b e antigen
ApplicantDIASORIN, INC.
PMA NumberP990043
Supplement NumberS011
Date Received01/29/2009
Decision Date02/25/2009
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 
Approval to move the manufacturing of the recombinant hbeag from a supplier to inside diasorin and to revise the qc procedure for purified r-hbe ag raw material acceptance.
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