therascreen FGFR RGQ RT-PCR Kit

FDA Premarket Approval P180043 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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

Devicetherascreen FGFR RGQ RT-PCR Kit
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbH
Date Received2021-09-20
Decision Date2021-11-16
PMAP180043
SupplementS003
Product CodeOWD 
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN GmbH qiagen Strasse 1 hilden 

Supplemental Filings

Supplement NumberDateSupplement Type
P180043Original Filing
S003 2021-09-20 Real-time Process
S002 2020-03-04 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
04053228034094 P180043 000

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