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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.
 
DeviceTHERASCREEN KRAS RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP110027
Supplement NumberS008
Date Received02/18/2015
Decision Date08/06/2015
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE) AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.
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