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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDIASORIN ETI-EBK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for hepatitis b e antigen
ApplicantDIASORIN, INC.
PMA NumberP990043
Date Received07/02/1999
Decision Date02/08/2001
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 01M-0454
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the diasorin eti-ebk plus assay. The device is indicated for the qualitative detection of hepatitis be antigen (hbeag) in human serum or plasma (edta, citrate or heparin). The eti-ebk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbeag is indicative of active hbv replication, usually correlating with viremia. A reactive test is presumptive laboratory evidence for infection with hepatitis b virus (hbv). Further hbv serological marker testing is required to define the specific disease state. The hbeag assay's performance has not been established for the monitoring of hbv disease or therapy.
Approval Order Approval Order
Supplements: S002 S003 S004 S005 S006 S007 S009 S010 S011 
S012 S013 S014 S015 S017 S018 S019 
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