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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 FGFR RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP180043
Supplement NumberS008
Date Received06/21/2024
Decision Date12/06/2024
Product Code OWD 
Advisory Committee Molecular Genetics
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Stability Study Protocol for the extension to the shelf-life and the implementation of a new storage condition for the positive control (PC) diluent for the therascreen FGFR RGQ RT-PCR Kit.
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