www.fdanews.com/articles/197190-korean-coronavirus-test-authorized-for-emergency-use
Korean Coronavirus Test Authorized for Emergency Use
May 19, 2020
The FDA has granted Emergency Use Authorization (EUA) to South Korean devicemaker 1-Drop for its COVID-19 qPCR multi-kit.
The polymerase chain reaction test uses nasopharyngeal or nasal swab specimens to detect the coronavirus.
The company said it plans to accelerate marketing of its test in North America.