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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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 
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