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

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Kit, Dna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Dna Detection, Human Papillomavirus

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

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

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

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

FDA Pre-Market Approval

FDA Class 3 ·TruSight Oncology Comprehensive

Cancer-Related Germline Gene Mutation Detection System

FDA classification

FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Somatic Gene Mutation Detection System

FDA classification

FDA Class 3 ·Somatic Gene Mutation Detection System

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

FDA Pre-Market Approval

FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

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

FDA classification

FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

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

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx