1,570 results · 27ms · Sources: EU EUDAMED, US FDA

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

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification
FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

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

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