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FDA Grants Emergency Use Authorization for Tetracore COVID-19 PCR Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for a molecular COVID-19 test developed by Tetracore.

The EZ-SARS-CoV-2 Real-Time RT-PCR test is designed for the qualitative detection of SARS-CoV-2 nucleic acid in mid-turbinate nasal swab specimens. Use of the in vitro diagnostic is limited to labs CLIA-certified to perform high-complexity tests, according to the FDA.

Rockville, Maryland-based Tetracore offers a range of antibody- and PCR-based tools and tests for human and animal health, as well as for biothreat preparedness, such as its T-Cor 8 portable real-time PCR thermocycler.