Federal Register: FDA Establishes Special Controls for LetsGetChecked Inc. Home-Collected Sexually Transmitted Infection Test Kits
October 09, 2026
October 09, 2026
WASHINGTON, Oct. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
* * *
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 Food and Drug Administration (FDA) is classifying the system for detection . . .
* * *
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 Food and Drug Administration (FDA) is classifying the system for detection . . .