Control Material, Her-2/Neu, Immunohistochemistry

FDA classification

FDA Class 2 ·Control Material, Her-2/Neu, Immunohistochemistry

Optical Coherence Tomography, Intravascular Catheter

FDA classification

FDA Class 2 ·Optical Coherence Tomography, Intravascular Catheter

Pump, Infusion, Insulin Bolus

FDA classification

FDA Class 2 ·Pump, Infusion, Insulin Bolus

Camera, Ophthalmic, General-Use

FDA classification

FDA Class 2 ·Camera, Ophthalmic, General-Use

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

FDA classification

FDA Class 2 ·Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Midline Catheter

FDA classification

FDA Class 2 ·Midline Catheter

Outpatient Cardiac Telemetry

FDA classification

FDA Class 2 ·Outpatient Cardiac Telemetry

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

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

Eustachian Tube Balloon Dilation Device

FDA classification

FDA Class 2 ·Eustachian Tube Balloon Dilation Device

Reprocessed Atherectomy Catheter

FDA classification

FDA Class 2 ·Reprocessed Atherectomy Catheter

Enzyme Immunoassay, Cortisol, Salivary

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Cortisol, Salivary

Bassinet, Hospital

FDA classification

FDA Class 2 ·Bassinet, Hospital

General Laparoscopic Power Morcellation Containment System

FDA classification

FDA Class 2 ·General Laparoscopic Power Morcellation Containment System

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification

FDA Class 2 ·Autosomal Recessive Carrier Screening Gene Mutation Detection System

Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

FDA classification

FDA Class 2 ·Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

Venous Window Needle Guide

FDA classification

FDA Class 2 ·Venous Window Needle Guide

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification

FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System