OWD · Somatic Gene Mutation Detection System

· Class 3

Overview

Product CodeOWD
Device NameSomatic Gene Mutation Detection System
Device ClassClass 3
Review Panel

Identification

The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.

Recent Cleared Devices (19 of 19)

RecordDevice NameApplicantDecision DateDecision
P220005CRCDx RAS Mutation Detection Assay KitEntrogen, Inc.Sep 29, 2023APPR
P210002therascreen PDGFRA RGQ PCR KitQIAGEN GmbHJun 29, 2023APPR
P200014cobas® EZH2 Mutation TestRoche Molecular System, Inc.Jun 18, 2020APPR
P190026therascreen BRAF V600E RGQ PCR KitQIAGEN GmbHApr 15, 2020APPR
P190004therascreen PIK3CA RGQ PCR KitQIAGEN GmbHMay 24, 2019APCB
P190001therascreen PIK3CA RGQ PCR KitQIAGEN GmbHMay 24, 2019APPR
P180043therascreen FGFR RGQ RT-PCR KitQIAGEN GmbHApr 12, 2019APPR
P170041Abbott RealTime IDH1Abbott Molecular, Inc.Jul 20, 2018APPR
P170005Abbott RealTime IDH2Abbott Molecular, Inc.Aug 1, 2017APPR
P160040LeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.Apr 28, 2017APPR
P150044cobas EGFR MUTATION TEST v2Roche Molecular Systems, Inc.Sep 28, 2016APCB
P150047cobas EGFR MUTATION TEST v2Roche Molecular Systems, Inc.Jun 1, 2016APCB
P140023COBAS KRAS MUTATION TESTRoche Molecular Systems, Inc.May 7, 2015APPR
P110027THERASCREEN KRAS RGQ PCR KITQIAGEN GmbHMay 23, 2014APPR
P120022THERASCREEN EGFR RGQ PCR KITQIAGEN GmbHJul 12, 2013APPR
P120014BIOMERIEUX THXID BRAF ASSAY KITbioMerieux, Inc.May 29, 2013APWD
P120019COBAS EGFR MUTATION TESTRocheMay 14, 2013APPR
P110030THERASCREEN KRAS RGQ PCR KITQIAGEN Manchester, Ltd.Jul 6, 2012APWD
P110020COBAS 4800 BRAF V600 MUTATION TESTRoche Molecular Systems, Inc.Aug 17, 2011APPR

Top Applicants

Innolitics

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