![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 » Detect’s COVID-19 Test Gets Emergency Use Authorization
Detect’s COVID-19 Test Gets Emergency Use Authorization
The FDA has granted an Emergency Use Authorization to Detect’s COVID-19 test, which can be performed at home and without a prescription.
The molecular in vitro diagnostic test is for qualitative detection of nucleic acid from the coronavirus SARS-CoV-2 which causes COVID-19 infections.
The test works on self-collected anterior nasal swab samples from people age 14 and up who may have COVID-19. It may also be administered with adult help to people age two to 13, the agency said.
Upcoming Events
-
21Oct