Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

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

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA classification

FDA Class 3 ·Tricuspid Valve Repair Device, Percutaneously Delivered

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System with Navigation and Touch

Test, Urea Adult And Pediatric (Breath),

FDA classification

FDA Class 3 ·Test, Urea Adult And Pediatric (Breath),

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect system

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA classification

FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

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

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit