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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 NumberS048
Date Received09/30/2022
Decision Date01/24/2023
Product Code NCD 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the addition of Sodium Heparin tubes as an alternative for blood collection in the workflow of the Quantiferon TB Gold Plus Test
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