title: Medical devices; immunology and microbiology devices; classification of dengue virus nucleic acid amplification test reagents. Final order.
abstract: The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D003715:Dengue / Q000097:blood*; D003716:Dengue Virus; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007202:Indicators and Reagents / Q000145:classification*; D021141:Nucleic Acid Amplification Techniques / Q000145:classification*; D012367:RNA, Viral / Q000032:analysis*; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014481:United States
chemical_list: D007202:Indicators and Reagents; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic