FDA.reportPublic FDA data

PMA P180043S003

Device
therascreen FGFR RGQ RT-PCR Kit
Applicant
QIAGEN GmbH
PMA number
P180043
Supplement
S003
Product code
OWD
Decision date
2021-11-16
Generic name
Somatic gene mutation detection system
Approval order statement
Approval for incorporation of a lower boundary for the therascreen FGFR RGQ RT-PCR assay CT cutoff and an update to the software and handbook to address this change.

Current openFDA PMA Record#

Device
therascreen FGFR RGQ RT-PCR Kit
Applicant
QIAGEN GmbH
PMA number
P180043
Supplement
S003
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2021-11-16
Decision code
APPR
Date received
2021-09-20
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 FGFR RGQ RT-PCR assay CT cutoff and an update to the software and handbook to address this change.