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Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens

FDA_FRDOC_0001-14365Final Rule

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Title: Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens

Posted: Jul 24, 2026
Comment period: Jul 24, 2026 – ?
Agency: Food and Drug Administration (FDA)
FR Doc: 2026-14985
CFR: 21 CFR Part 866

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