735 results · 18ms · Sources: EU EUDAMED, US FDA

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Somatic Gene Mutation Detection System

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

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·INTERTACH TM IMPLANTABLE PACEMAKER PULSE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·RealTime IDH1

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER

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 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas EFGR Mutation Test, v2.0

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·TELECTRONICS PASAR MODEL 4171 PG

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test v2

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·INTERTACH(R)II MODELS 262-16

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

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