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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.
 
DeviceQIAGEN therascreen® KRAS RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP110027
Supplement NumberS016
Date Received09/06/2023
Decision Date10/06/2023
Product Code OWD 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the Instructions For Use to strengthen information in relation to interpretation of results for patients with colorectal cancer and non-small cell lung cancer to enhance the safety of the QIAGEN therascreen KRAS RGQ PCR Kit.
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