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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-AB-EBK PLUS ASSAY
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP990041
Supplement NumberS004
Date Received01/30/2004
Decision Date02/20/2004
Withdrawal Date10/10/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
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