![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 » Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test
Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test
![emergency use authorization approved](https://www.fdanews.com/ext/resources/test/Drug-Images4/emergency-use-authorization-EUA-approved.gif?t=1586211479&width=430)
Eurofins has received Emergency Use Authorization (EUA) from the FDA for the direct-to-consumer version of its EmpowerDX COVID-19 Home Collection Kit.
The at-home COVID-19 nasal polymerase chain reaction (PCR) kit can be sold directly to consumers without a prescription and can be ordered online for $99, the company said.
The test kit includes a nasal swab, a test tube and a pre-paid shipping package used to send samples for analysis. Results are posted on a secure patient portal within 48 hours, Eurofins said.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct