2,708 results · 38ms · Sources: EU EUDAMED, US FDA

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 ·therascreen PIK3CA RGQ PCR Kit

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 ·LeukoStrat CDx FLT3 Mutation Assay

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 ·RealTime IDH2

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 ·Cobas 4800 BRAF V600 Mutation Test

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

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

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 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 ·therascreen® KRAS RGQ PCR Kit

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 ·cobas EGFR Mutation Test v2

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 ·cobas EGFR Mutation Test v2