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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
ApplicantQIAGEN
19300 Germantown Road
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS023
Date Received12/23/2013
Decision Date01/31/2014
Product Code NCD 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO INCORPORATE NEW BRANDING IN THE LABELING, TIGHTEN AN IN-PROCESS QC SPECIFICATION FOR THE BLOOD COLLECTION TUBES, AND ADD STEPS TO A RAW MATERIAL ACCEPTANCE PROCEDURE.
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