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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 | S003 |
Date Received | 09/20/2021 |
Decision Date | 11/16/2021 |
Product Code |
OWD |
Advisory Committee |
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Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for incorporation of a lower boundary for the therascreen FGFR RGQ RT-PCR assay CT cutoff and an update to the software and handbook to address this change. |