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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.
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP990041
Date Received07/02/1999
Decision Date03/30/2001
Docket Number 01M-0452
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the diasorin eti-ab-ebk plus assay. The device is indicated for: eti-ab-ebk plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative detection of total antibodies to hepatitis b e antigen (anti-hbe) in human serum or plasma (edta, citrate or heparin). The eti-ab-ebk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of anti-hbe is indicative of laboratory diagnosis for seroconversion and progression to hepatitis b virus (hbv) clearance. A reactive test is presumptive laboratory evidence of hbv seroconversion. Further hbv serological marker testing is required to define the specific disease state. The anti-hbe assay's performance has not been established for the monitoring of hbv disease or therapy.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S016 S017 S018 S019 S020