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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 assay and Control
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP180047
Supplement NumberS014
Date Received02/04/2022
Decision Date05/05/2022
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 to allow the LIAISON XL Analyzer to be connected to the Beckman DxA 5000, an FDA-cleared third party Laboratory Automation System (LAS).
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