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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 NumberS013
Date Received01/19/2022
Decision Date12/12/2022
Product Code OWD 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib).
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