![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Yale’s Saliva Test for COVID-19 Gets Renewed EUA
Yale’s Saliva Test for COVID-19 Gets Renewed EUA
![Yale logo](https://www.fdanews.com/ext/resources/test/Drug-Images4/Yale-logo.gif?t=1631046869&width=430)
Yale University’s SalivaDirect direct-to-consumer (DTC) saliva collection kit has received a renewed Emergency Use Authorization from the FDA for use with the SalivaDirect test to detect the SARS-CoV-2 virus that causes COVID-19 in individuals without symptoms.
The DTC kit, which includes a bulb pipette and a labeled tube with a funnel, is meant for self-collection of saliva samples at home or in a community-based setting by people age 18 and up.
Testing of the self-collected saliva samples may only be done by laboratories designated by the Yale School of Public Health, including Yale’s clinical molecular diagnostics laboratory in New Haven, Conn.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct