Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis Nucleic Acid Assay. Final order

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    Federal Register
    |August 6, 2015
    PubMed

    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.

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