System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Prognostic Test For Assessment Of Liver Related Disease Progression

FDA classification

FDA Class 2 ·Prognostic Test For Assessment Of Liver Related Disease Progression

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Serpina1 Variant Detection System

FDA classification

FDA Class 2 ·Serpina1 Variant Detection System

Chronic Lymphocytic Leukemia Fish Probe Kit

FDA classification

FDA Class 2 ·Chronic Lymphocytic Leukemia Fish Probe Kit

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Fracture

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Mechanical Ventilator

FDA classification

FDA Class 2 ·Mechanical Ventilator

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification

FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Stimulator, Intramuscular, Automatic

FDA classification

FDA Class 2 ·Stimulator, Intramuscular, Automatic

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA classification

FDA Class 2 ·Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

FDA classification

FDA Class 2 ·High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Microbial Colony Image Assessment System

FDA classification

FDA Class 2 ·Microbial Colony Image Assessment System

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

FDA classification

FDA Class 2 ·Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management