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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.
 
DeviceQuantiFERON-TB Gold Plus Test
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQiagen
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS051
Date Received08/28/2025
Decision Date11/21/2025
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 design change to the device TB Antigen blood collection tubes (QuantiFERON TB Gold Pro Blood Collection Tubes) with the QuantiFERON-TB Gold Plus Test
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