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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® FGFR RGQ RT-PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP180043
Supplement NumberS010
Date Received02/17/2026
Decision Date05/06/2026
Product Code OWD 
Advisory Committee Molecular Genetics
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a minor material change which would replace the BSA (Bovine Serum Album) in the PCR Master Mix tubes with a recombinant Human Serum Albumin (rHSA).
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