41 results · 28ms · Sources: EU EUDAMED, US FDA

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Serpina1 Variant Detection System

FDA classification
FDA Class 2 ·Serpina1 Variant Detection System

Revumenib Eligibility Detection System

FDA classification
FDA Class 2 ·Revumenib Eligibility Detection System

Gastrointesinal Lesion Software Detection System

FDA classification
FDA Class 2 ·Gastrointesinal Lesion Software Detection System

Kit D816v Mutation Detection System

FDA classification
Kit D816v Mutation Detection System

Coronavirus Antigen Detection Test System.

FDA classification
FDA Not Classified ·Coronavirus Antigen Detection Test System.

Somatic Gene Mutation Detection System

FDA classification
FDA Class 3 ·Somatic Gene Mutation Detection System

Candida Species Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Candida Species Nucleic Acid Detection System

Setmelanotide Eligibility Gene Variant Detection System

FDA classification
FDA Class 2 ·Setmelanotide Eligibility Gene Variant Detection System

Ir Laser Intrusion Detection/Security System

FDA classification
FDA Not Classified ·Ir Laser Intrusion Detection/Security System

Cabinet X-Ray Explosive Detection Systems

FDA classification
FDA Not Classified ·Cabinet X-Ray Explosive Detection Systems

Direct Blood Bacterial Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Direct Blood Bacterial Nucleic Acid Detection System

Lower Respiratory Microbial Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Lower Respiratory Microbial Nucleic Acid Detection System

System, Detection, Bacterial, For Platelet Transfusion Products

FDA classification
FDA Class 1 ·System, Detection, Bacterial, For Platelet Transfusion Products

Colon Computed Tomography System, Computer Aided Detection

FDA classification
FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

Cancer-Related Germline Gene Mutation Detection System

FDA classification
FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

Lung Computed Tomography System, Computer-Aided Detection

FDA classification
FDA Class 2 ·Lung Computed Tomography System, Computer-Aided Detection

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Autosomal Recessive Carrier Screening Gene Mutation Detection System

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

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Genetic Variant Detection And Health Risk Assessment System

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