Radiological Computer-Assisted Prioritization Software For Lesions

FDA classification

FDA Class 2 ·Radiological Computer-Assisted Prioritization Software For Lesions

Dental Abutment Design Software For Dental Laboratory

FDA classification

FDA Class 2 ·Dental Abutment Design Software For Dental Laboratory

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

FDA classification

FDA Class 2 ·System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Radiological Computer-Assisted Triage And Notification Software

FDA classification

FDA Class 2 ·Radiological Computer-Assisted Triage And Notification Software

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA classification

FDA Class 2 ·Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

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