754 results · 20ms · Sources: EU EUDAMED, US FDA

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Epi proColon

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard®

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologaurd

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·COLOGUARD

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval
FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Somatic Gene Mutation Detection System

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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Express Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·Therakos Cellex Photopheresis System

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 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PREPSTAIN SYSTEM