therascreen KRAS RGQ PCR Kit
FDA premarket approval P110027/S013 · decided 2022-12-12
Approval details
- PMA number
- P110027
- Supplement
- S013
- Supplement type
- Normal 180 Day 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
- 2022-01-19
- Decision date
- 2022-12-12
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib).
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