therascreen BRAF V600E RGQ PCR Kit

FDA Premarket Approval P190026

Pre-market Approval Supplement Details

Approval for the therascreen braf v600e rgq pcr kit. The therascreen braf v600e rgq pcr kit is a real-time pcr test for the qualitative detection of v600e mutations in the braf gene using genomic dna extracted from formalin-fixed paraffin-embedded (ffpe) human colorectal cancer (crc) tumor tissue. The therascreen braf v600e rgq pcr kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mcrc) whose tumors carry the braf v600e mutation for treatment with braftovi (encorafenib) in combination with cetuximab. The therascreen braf v600e rgq pcr kit is for use on the rotor-gene q mdx (us) instrument. The therascreen braf v600e rgq pcr kit is intended for in vitro diagnostic use.

Devicetherascreen BRAF V600E RGQ PCR Kit
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbH
Date Received2019-09-30
Decision Date2020-04-15
PMAP190026
SupplementS
Product CodeOWD 
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN GmbH qiagen Strasse 1 hilden 40724
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P190026Original Filing

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