91 results
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40ms
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Sources: EU EUDAMED, US FDA
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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
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
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