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

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 BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BIOMERIEUX THXID BRAF ASSAY 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 ·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 KRAS MUTATION TEST

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 ·CYBERTACH

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 ·therascreen KRAS RGQ PCR KIT

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

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

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

Pulse-Generator, Single Chamber, Single

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID-BRAF KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Somatic Gene Mutation Detection System

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