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Device | therascreen FGFR RGQ RT-PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH Qiagen Strasse 1 Hilden |
PMA Number | P180043 |
Supplement Number | S005 |
Date Received | 08/21/2023 |
Decision Date | 09/15/2023 |
Product Code |
OWD |
Advisory Committee |
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing process and QC specification improvements for device components. |