Premarket Approval (PMA)

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.

• Device: therascreen FGFR RGQ RT-PCR Kit
• Generic Name: Somatic gene mutation detection system
• Applicant: QIAGEN GmbH; Qiagen Strasse 1; Hilden 40724
• PMA Number: P180043
• Supplement Number: S009
• Date Received: 09/26/2024
• Decision Date: 10/23/2024
• Product Code: OWD
• Advisory Committee: Molecular Genetics
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
manufacturing process transfer of a single component to an approved site