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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-AB-COREK PLUS ASSAY
Generic Nameeia for total antibodies to hepatitis b core antigen
ApplicantDIASORIN S.P.A.
PMA NumberP990045
Date Received07/02/1999
Decision Date03/30/2001
Docket Number 01M-0456
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-ab-corek plus assay. The device is indicated for: eti-ab-corek plus is ian in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum or plasma (edta, citrate or heparin). The eti-ab-corek plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of total anti-hbc is indicative of a laboratory diagnosis for exposure to hepatitis b virus (hbv) infection. Further hbv serological marker testing is required to define the specific disease state. The eti-ab-corek plus 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 S008 
S009 S010 S011 S012 S014 
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