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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 EGFR RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP120022
Supplement NumberS012
Date Received09/28/2015
Decision Date11/09/2015
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.
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