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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 NumberS005
Date Received12/22/2014
Decision Date01/16/2015
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE SUPPLIER¿S PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN EGFR RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%.
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