Jiangsu Bioperfectus Gets Emergency Use Authorization for Coronavirus Test Kit

The FDA has 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.

“No descriptive printed matter, including advertising or promotional materials, relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2,” the agency said.