276 results · 46ms · Sources: EU EUDAMED, US FDA

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification
FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

FDA classification
FDA Class 2 ·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Lynch Syndrome Test System

FDA classification
FDA Class 2 ·Lynch Syndrome Test System

Nucleic Acid Quantitation Kit

FDA classification
FDA Class 1 ·Nucleic Acid Quantitation Kit

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification
FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

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

Drug Metabolizing Enzyme Genotyping Systems

FDA classification
FDA Class 2 ·Drug Metabolizing Enzyme Genotyping Systems

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification
FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

Reagents For Molecular Diagnostic Test Systems

FDA classification
FDA Class 1 ·Reagents For Molecular Diagnostic Test Systems

Neurologic Disease Risk Assessment Molecular Test

FDA classification
FDA Class 2 ·Neurologic Disease Risk Assessment Molecular Test

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

Serpina1 Variant Detection System

FDA classification
FDA Class 2 ·Serpina1 Variant Detection System

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification
FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Cancer Predisposition Risk Assessment System

FDA classification
FDA Class 2 ·Cancer Predisposition Risk Assessment System