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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 Test and QuantiFERON®-TB Gold Plus Test
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQiagen
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS052
Date Received12/30/2025
Decision Date01/23/2026
Product Code NCD 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an internal site to internal site transfer of a manufacturing process
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