title: Medical devices; immunology and microbiology devices; classification of dengue virus serological reagents. Final order.
abstract: The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. 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*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007159:Immunologic Tests / Q000145:classification* / Q000295:instrumentation*; D007202:Indicators and Reagents / Q000145:classification*; D008828:Microbiological Techniques / Q000145:classification* / Q000295:instrumentation*; D012699:Serology / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007202:Indicators and Reagents