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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 / QuantiFERON TB Gold Plus Test
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantQIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS041
Date Received09/25/2018
Decision Date10/30/2018
Product Code NCD 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for change in critical raw material of kit component.
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