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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceQUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQIAGEN
19300 Germantown Road
Germantown, MD 20874
PMA NumberP010033
Date Received06/01/2001
Decision Date11/28/2001
Product Code NCD 
Docket Number 02M-0218
Notice Date 05/13/2002
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CELLESTIS QUANTIFERON-TB. THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S019  S018 S023 S020 S024 S006 S007 S009 S010 S001 S014 
S015 S016 S005 S029 S030 S031 S033 S025 S026 S002 S003 S004 
S011 S017 S012 S013 S028 S032 S034 S035 S036 S039 S044 S045 
S047 S038 S037 S040 S041 S042 S043 S046 S048 S049 S050 
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