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Westminster International Ltd marketed thermal camera products (WG 520 and WG 620) as devices intended to screen for, detect, and diagnose COVID-19 and other infectious diseases without obtaining required FDA clearance or approval, making them adulterated and misbranded under federal law. The company's websites explicitly positioned these temperature-measurement devices as "Coronavirus Covid-19, Flu, Ebola Screening Systems" and stated they were "designed by medical professionals to be used as a first level mass screening test for identifying individuals that have an above normal body temperature and may be suffering from Coronavirus" and other pathogens. By making disease claims without proper regulatory authorization, the products violated the Federal Food, Drug, and Cosmetic Act's requirements for medical devices intended to diagnose, treat, prevent, or mitigate disease.