Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel. Final order
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The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will ... ...
