2,480 results · 28ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

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

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

Somatic Gene Mutation Detection System

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

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM IMPLANTABLE HEARING SYSTEM

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

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·Esteem

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

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

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

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

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 ·therascreen FGFR RGQ RT-PCR Kit

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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