5,736 results · 47ms · Sources: EU EUDAMED, US FDA

RealTime

FDA UDI
ABBOTT MOLECULAR INC.·00884999047044·Abbott RealTime IDH2 Amplification Reagent Kit

cobas&#x00AE EZH2 Mutation Test

FDA UDI
Roche Molecular Systems, Inc.·00875197005592·

LeukoStrat

FDA UDI
INVIVOSCRIBE, INC.·00850052003685·The LeukoStrat CDx FLT3 Mutation Assay targets ...

RealTime

FDA UDI
ABBOTT MOLECULAR INC.·00884999047341·Abbott RealTime IDH1 Control Kit

THxID™ BRAF

FDA UDI
BIOMERIEUX SA·03573026559823·Software used in combination with the THxIDTM- ...

cobas® DNA Sample Preparation Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197004120·

therascreen® KRAS RGQ PCR Kit

FDA UDI
QIAGEN GmbH·04053228002048·

RealTime

FDA UDI
ABBOTT MOLECULAR INC.·00884999047358·Abbott RealTime IDH1 Amplification Reagent Kit

cobas® EGFR Mutation Test

FDA UDI
Roche Molecular Systems, Inc.·00875197004229·

cobas® EGFR Mutation Test v2

FDA UDI
Roche Molecular Systems, Inc.·00875197005448·

therascreen® FGFR RGQ RT-PCR Kit

FDA UDI
QIAGEN GmbH·04053228043560·The therascreen FGFR RGQ RT-PCR Kit is a real-t...

cobas® 4800 BRAF V600 Mutation Test

FDA UDI
Roche Molecular Systems, Inc.·00875197004137·

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS KRAS MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID BRAF assay kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas KRAS Mutation Test