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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 and QuantiFeron TB Gold Plus
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantQIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS038
Date Received01/26/2018
Decision Date02/23/2018
Product Code NCD 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Establishment of an outside firm as an additional manufacturing site for a portion of the production for a kit component.
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