COVID-19 diagnostic testing device FDA EUA authorized COVID-19 diagnostic testing device Asiyah Yu Lin, Oliver He, Bill Duncan a COVID-19 diagnostic testing device that is authorized to use under the FDA Emergency Use Authorization. The EUA authorized device is not approved to use under other situations other than specified in the letter of EUA authorization by FDA in US. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas