Business · 09/10/2026

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

The US Food and Drug Administration (FDA) is classifying a system for detecting nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens into Class II.

Source: Federal Register — Health and Human ServicesOpen original release →

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