1,856 results · 24ms · Sources: EU EUDAMED, US FDA

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification
FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification
FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

FDA classification
FDA Class 2 ·Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

Assay, Proliferation, In Vitro, T Lymphocyte

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

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

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification
FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Cancer Predisposition Risk Assessment System

FDA classification
FDA Class 2 ·Cancer Predisposition Risk Assessment System