PMA P120022S016

Device: Therascreen EGFR RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S016
Product code: OWD
Decision date: 2018-01-12
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.

Current openFDA PMA Record#

Device: Therascreen EGFR RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S016
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2018-01-12
Decision code: APPR
Date received: 2017-07-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.