title: Medical Devices; Immunology and Microbiology Devices;   Classification of Gastrointestinal Microorganism Multiplex Nucleic   Acid-Based Assay. Final order.
abstract: The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D005243:Feces / Q000382:microbiology; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000382:microbiology*; D006801:Humans; D008828:Microbiological Techniques / Q000145:classification* / Q000295:instrumentation*; D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014481:United States
chemical_list: D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic