FDA.reportPublic FDA data

PMA P120022S020

Device
therascreen EGFR RGQ PCR Kit
Applicant
QIAGEN GmbH
PMA number
P120022
Supplement
S020
Product code
OWD
Decision date
2019-09-26
Classification
Somatic Gene Mutation Detection System
Generic name
Somatic gene mutation detection system
Approval order statement
Approval for updates to the limitations section of the instructions for use to include additional cross-reactivity information for the therascreen® EGFR RGQ PCR Kit.

Current openFDA PMA Record#

Device
therascreen EGFR RGQ PCR Kit
Applicant
QIAGEN GmbH
PMA number
P120022
Supplement
S020
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2019-09-26
Decision code
APPR
Date received
2019-08-28
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to the limitations section of the instructions for use to include additional cross-reactivity information for the therascreen® EGFR RGQ PCR Kit.