Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

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 ·THERASCREEN EGFR RGQ PCR KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx device

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

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

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Wearable Automated External Defibrillator

FDA classification

FDA Class 3 ·Wearable Automated External Defibrillator

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test