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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
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
Applicant
QIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Date Received06/01/2001
Decision Date11/28/2001
Product Code
NCD[ Registered Establishments with NCD ]
Docket Number 02M-0218
Notice Date 05/13/2002
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S023 S024 S025 S026 S028 S029 S030 S031 
S032 S033 S034 
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