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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.
 
DeviceLIAISON QuantiFERON-TB Gold Plus, LIAISON XL Control QuantiFERON-TB Gold Plus
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP180047
Supplement NumberS010
Date Received05/27/2021
Decision Date08/10/2021
Product Code NCD 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a software version change for the LIAISON XL Analyzer from the approved LIAISON XL version 4.2.2.3 SP1 to software version 4.2.2.4.
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