2,708 results
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41ms
·
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
·THERASCREEN KRAS RGQ PCR KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
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® BRAF V600 Mutation Test
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
·ROCHE COBAS 4800 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
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·QIAGEN THERASCREEN EGFR RGQ PCR KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS 4800 BRAF V600 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
·Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test
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
·LeukoStrat CDx FLT3 Mutation Assay
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
·Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·Vysis ALK Break Apart Fish Probe Kit
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat® CDx FL T3 Mutation Assay
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THERASCEEN EGFR RGQ PCR KIT