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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-HAVK PLUS ASSAY
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDiasorin
1951 Northwestern Ave.
P.O. Box 285
Stillwater, MN 55082
PMA NumberP890019
Supplement NumberS009
Date Received01/30/2004
Decision Date02/20/2004
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
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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