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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 II; LIAISON Control QuantiFERON TB Gold Plus II
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP180047
Supplement NumberS039
Date Received07/30/2025
Decision Date01/26/2026
Product Code NCD 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the formulation of antibody and buffer reagents, changes to the assay component layout, changes to the assay protocol, introduction of the new trade name LIAISON QuantiFERON - TB Gold Plus II, LIAISON Control QuantiFERON - TB Gold Plus II, the addition of new suppliers for raw materials, and revisions to packaging and device labeling.
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