On June 18th, US Food & Drug Administration granted China’s Jiangsu Bioperfectus Technologies an Emergency Use Authorization for its COVID-19 Coronavirus Real-Time PCR Kit.

The authorization requires that all promotional materials for the polymerase-chain-reaction (PCR) test clearly state that the test has not been cleared or approved by the FDA and must be used only by authorized laboratories.

Further read: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas