FDA.reportPublic FDA data

PMA P120022S022

Device
therascreen EGFR RGQ PCR Kit
Applicant
QIAGEN GmbH
PMA number
P120022
Supplement
S022
Product code
OWD
Decision date
2021-07-07
Generic name
Somatic gene mutation detection system
Approval order statement
Approval for incorporation of a lower boundary for the therascreen EGFR RGQ PCR assay Ct cutoff range and an update to the software and handbook to address this change.

Current openFDA PMA Record#

Device
therascreen EGFR RGQ PCR Kit
Applicant
QIAGEN GmbH
PMA number
P120022
Supplement
S022
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2021-07-07
Decision code
APPR
Date received
2020-10-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for incorporation of a lower boundary for the therascreen EGFR RGQ PCR assay Ct cutoff range and an update to the software and handbook to address this change.