U.S. FDA Gives Emergency Use Authorization to Korean COVID-19 Diagnostic Kits

The U.S. FDA announced on April 18 that it gave an emergency use authorization to Osang Health Care’s RT-PCR COVID-19 diagnostic kits. The authorization is effective until the coronavirus disappears and the company’s kits can be used only in authorized laboratories.

Osang Health Care is the first South Korean COVID-19 diagnostic kit manufacturer that obtained the emergency use authorization from the U.S. FDA. On April 15, SD Biosensor, Solgent and Osang Health Care signed a US$11.4 million contract with the Federal Emergency Management Agency to export COVID-19 diagnostic kits for 750,000 tests.

Some other South Korean companies, including Seegene, are currently exporting their kits to the United States regardless of the U.S. FDA’s emergency use authorization. U.S. labs with the CLIA certificate can use such kits without the FDA authorization.