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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.

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