therascreen FGFR RGQ PCR Kit

FDA Premarket Approval P180043 S002

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

Changes to in-process qc testing

Devicetherascreen FGFR RGQ PCR Kit
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbH
Date Received2020-03-04
Decision Date2020-04-03
PMAP180043
SupplementS002
Product CodeOWD 
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
04053228043560 P180043 001

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