PMA P110027S014

Device: therascreen KRAS RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S014
Product code: OWD
Decision date: 2022-06-17
Generic name: Somatic gene mutation detection system
Approval order 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.

Current openFDA PMA Record#

Device: therascreen KRAS RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S014
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2022-06-17
Decision code: APPR
Date received: 2022-05-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.