Neurologic Disease Risk Assessment Molecular Test

FDA classification

FDA Class 2 ·Neurologic Disease Risk Assessment Molecular Test

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Genetic Variant Detection And Health Risk Assessment System

FDA classification

FDA Class 2 ·Genetic Variant Detection And Health Risk Assessment System

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification

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

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

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

Serpina1 Variant Detection System

FDA classification

FDA Class 2 ·Serpina1 Variant Detection System

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System

Next Generation Sequencing Based Tumor Profiling Test

FDA classification

FDA Class 2 ·Next Generation Sequencing Based Tumor Profiling Test

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Software Algorithm Device To Assist Users In Digital Pathology

FDA classification

FDA Class 2 ·Software Algorithm Device To Assist Users In Digital Pathology

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

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

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Digital Pathology Display

FDA classification

FDA Class 2 ·Digital Pathology Display