735 results
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17ms
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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 EGFR MUTATION TEST
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
·INTERTACH(R)II MODELS 262-16
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 IMPLANT. PACEMAKER PULSE GENERATOR
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 4800 BRAF V600 Mutation Test
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
·LeukoStrat CDx FLT3 Mutation Assay
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 EGFR Mutation Test v2
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
·therascreen PDGFRA 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
·THERASCREEN EGFR RGQ PCR KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas KRAS Mutation Test
Pulse-Generator, Single Chamber, Single
FDA Pre-Market Approval
FDA Class 3
·CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THERASCREEN KRAS RGQ PCR KIT