www.fdanews.com/articles/205295-talis-biomedical-gets-eua-for-talis-one-covid-19-test-system
Talis Biomedical Gets EUA for Talis One COVID-19 Test System
November 11, 2021
Menlo Park, Calif.-based Talis Biomedical has received the FDA’s Emergency Use Authorization (EUA) for its Talis One COVID-19 test system.
The FDA has authorized it for the qualitative detection of nucleic acid from the SARS-CoV-2 coronavirus that causes COVID-19 in nasal mid-turbinate swab specimens.
The diagnostic system is a qualitative in vitro real-time nucleic acid amplification test to be used in individuals suspected of having COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988.