|
Device | therascreen® KRAS RGQ PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P110027 |
Supplement Number | S017 |
Date Received | 02/07/2024 |
Decision Date | 06/21/2024 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expanding the indication to aid in the identification of colorectal cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib) in combination with ERBITUX (cetuximab) |