title: Medical Devices; Immunology and Microbiology Devices;   Classification of Trichomonas Vaginalis Nucleic Acid Assay. Final order.
abstract: The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid 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; D005260:Female; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000145:classification* / Q000295:instrumentation*; D014247:Trichomonas Vaginitis / Q000175:diagnosis / Q000382:microbiology; D014246:Trichomonas vaginalis / Q000382:microbiology*; D014481:United States