www.fdanews.com/articles/205726-auderes-healthpulsehome-covid-19-test-gets-fdas-emergency-use-authorization
Audere’s HealthPulse@home COVID-19 Test Gets FDA’s Emergency Use Authorization
December 10, 2021
The FDA has issued an Emergency Use Authorization to Seattle, Wash.-based Audere for its HealthPulse@home COVID-19 test collection kit.
Nasal swab samples collected at home using the kit are shipped at ambient temperature for testing in a laboratory.
If present in the sample, RNA from the SARS-CoV-2 virus that causes COVID-19 infection is detected using an approved molecular diagnostic test.