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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
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantQIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS003
Date Received02/20/2003
Decision Date03/17/2003
Product Code NCD 
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).
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