FDA:Jiangsu Bioperfectus Gets Emergency Use Authorization for Coronavirus Test Kit

Company news

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



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