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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIASORIN ETI-EBK PLUS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990043
Supplement NumberS006
Date Received03/11/2004
Decision Date03/26/2004
Withdrawal Date 10/10/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI- EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.
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