QIAGEN therascreen® KRAS RGQ PCR Kit
FDA premarket approval P110027/S016 · decided 2023-10-06
Approval details
- PMA number
- P110027
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QIAGEN therascreen® KRAS RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2023-09-06
- Decision date
- 2023-10-06
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for an update to the Instructions For Use to strengthen information in relation to interpretation of results for patients with colorectal cancer and non-small cell lung cancer to enhance the safety of the QIAGEN therascreen KRAS RGQ PCR Kit.
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