FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Issues Emergency Use Authorization for Ebola Fingerstick Test

Nov. 16, 2018
A A

The FDA granted an emergency use authorization (EUA) for Chembio’s single-use, rapid fingerstick test for the Ebola virus, only the second test of its kind made available under an EUA.

The EUA authorization — which has been declared in the midst of the deadly pathogen’s outbreak in the Democratic Republic of the Congo — allows unapproved medical products to be used in emergency situations when there are no approved alternatives available.

The Dual Path Platform Ebola Antigen System detects the virus in blood samples from patients that exhibit symptoms of the disease and other risk factors.

View today's stories