therascreen KRAS RGQ PCR Kit
FDA premarket approval P110027/S014 · decided 2022-06-17
Approval details
- PMA number
- P110027
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- therascreen KRAS RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2022-05-19
- Decision date
- 2022-06-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for changes to the instructions for use (IFU) to strengthen information in relation to interpretation of results for NSCLC patients to enhance the safety of the QIAGEN therascreen KRAS RGQ PCR Kit.
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| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
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| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| QIAstat-Dx Respiratory Panel Mini (K242353) | QIAGEN GmbH | 2024-10-25 |