Barrier, Animal Source, Intraoral

FDA classification

FDA Class 2 ·Barrier, Animal Source, Intraoral

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

FDA classification

FDA Class 2 ·Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

11-Dehydro Thromboxane B2 Kit, Urinary

FDA classification

FDA Class 2 ·11-Dehydro Thromboxane B2 Kit, Urinary

Bacteriophage And Controls, B. Anthracis Lysis

FDA classification

FDA Class 2 ·Bacteriophage And Controls, B. Anthracis Lysis

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA classification

FDA Class 2 ·Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

Breast Milk Macronutrients Test System

FDA classification

FDA Class 2 ·Breast Milk Macronutrients Test System

Anti-Phospholipase A2 Receptor

FDA classification

FDA Class 2 ·Anti-Phospholipase A2 Receptor

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

FDA classification

FDA Class 2 ·Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Brain Trauma Assessment Test

FDA classification

FDA Class 2 ·Brain Trauma Assessment Test

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

FDA Class 2 ·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Phase-Changing Fiducial Marker For Radiation Therapy

FDA classification

FDA Class 2 ·Phase-Changing Fiducial Marker For Radiation Therapy

Procalcitonin Assay

FDA classification

FDA Class 2 ·Procalcitonin Assay

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

FDA classification

FDA Class 2 ·Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Thermometer, Exhaled Breath

FDA classification

FDA Class 2 ·Thermometer, Exhaled Breath

Lens, Contact, For Reading Discomfort

FDA classification

FDA Class 2 ·Lens, Contact, For Reading Discomfort

Anti-Ss-A Ro60 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A Ro60 Autoantibodies

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA classification

FDA Class 2 ·Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Dental Image Analyzer

FDA classification

FDA Class 2 ·Dental Image Analyzer