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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
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
Applicant
QIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS010
Date Received02/14/2006
Decision Date03/10/2006
Product Code NCD 
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABLEING CHANGE TO THE WORDING OF THE INTERPRETATION OF THE TEST TO REMOVE AMBIGUITY AND ENHANCE SAFE USE.
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