www.fdanews.com/articles/205187-detects-covid-19-test-gets-emergency-use-authorization
Detect’s COVID-19 Test Gets Emergency Use Authorization
November 4, 2021
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.