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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.
 
DeviceETI-AB-AUK PLUS ASSAY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990042
Supplement NumberS011
Date Received02/17/2012
Decision Date03/09/2012
Withdrawal Date 10/10/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
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