Rule Health and Human Services DepartmentFood and Drug Administration May 6, 2026

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples

The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples into class II (special controls). The...

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Document type: Rule. Agency: Health and Human Services Department, Food and Drug Administration. Published: 2026-05-06.

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