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

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Zika Virus Serological Reagents (Emergency Use)

FDA classification

FDA Not Classified ·Zika Virus Serological Reagents (Emergency Use)

Collector, Urine, Powered, Non Indwelling Catheter

FDA classification

FDA Class 1 ·Collector, Urine, Powered, Non Indwelling Catheter

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification

FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Devices Detecting Influenza A, B, And C Virus Antigens

FDA classification

FDA Class 2 ·Devices Detecting Influenza A, B, And C Virus Antigens

Test For Periprosthetic Joint Infection

FDA classification

FDA Not Classified ·Test For Periprosthetic Joint Infection

Wearable Vibration Device For Orthopedic Use

FDA classification

FDA Class 2 ·Wearable Vibration Device For Orthopedic Use

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

FDA classification

FDA Class 2 ·Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification

FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA classification

FDA Class 2 ·Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Laser Target Designator

FDA classification

FDA Not Classified ·Laser Target Designator

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

FDA classification

FDA Class 2 ·Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification

FDA Class 3 ·Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification

FDA Class 3 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Polymeric Neurovascular Embolization

FDA classification

Polymeric Neurovascular Embolization

Low Energy Direct Current Thermal Ablation System

FDA classification

FDA Class 2 ·Low Energy Direct Current Thermal Ablation System

Aortic Stent

FDA classification

FDA Class 3 ·Aortic Stent

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

FDA classification

FDA Class 1 ·Immunoassay, Insulin-Like Growth Factor Binding Protein-1