283 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
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
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
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
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 IDH2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas® EZH2 Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay