735 results · 25ms · Sources: EU EUDAMED, US FDA

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

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 ·QIAGEN THERASCREEN KRAS RGQ 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 ·THxID-BRAF kit

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 4800 BRAF V600 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 ·Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·INTERTACH(R)II & RX2000(R) GRAPHICS PROGRAM MODULE

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

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 ·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