therascreen EGFR RGQ PCR Kit
FDA premarket approval P120022/S022 · decided 2021-07-07
Approval details
- PMA number
- P120022
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- therascreen EGFR RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2020-10-23
- Decision date
- 2021-07-07
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for incorporation of a lower boundary for the therascreen EGFR RGQ PCR assay Ct cutoff range and an update to the software and handbook to address this change.
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|---|---|---|
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| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329) | QIAGEN GmbH | 2025-10-22 |
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| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
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| QIAstat-Dx Respiratory Panel Mini (K242353) | QIAGEN GmbH | 2024-10-25 |