emergency use authorization approved

DiaCarta Gets Emergency Use Authorization for COVID-19 Diagnostic

April 13, 2020

DiaCarta received an Emergency Use Authorization (EUA) from the FDA for its QuantiVirus PCR diagnostic for detecting SARS-CoV-2.

The test can detect all currently known strains of the virus using nasal, throat or sputum samples, and delivers results within two hours.

The company said it has ramped up its manufacturing operations and is now able to produce 500,000 tests a week, and plans to expand its capabilities on an even larger scale.

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