2,708 results · 40ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

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 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas 4800 BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test, V2.0

Somatic Gene Mutation Detection System

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

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 BRAF V600 Mutation Test