Abbott received FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity mル System

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On May 12, 2020, Abbott announced the FDA issued an Emergency Use Authorization (EUA) for the company’s molecular test for the novel coronavirus (COVID-19) for use on its new Alinityル m molecular laboratory instrument. Abbott is in the process of launching the Alinity m system to U.S. customers.

The Alinity m system was cleared by the FDA for use with Abbott’s HCV (hepatitis C) assay in late March. Abbott is working with hospitals and health systems in the U.S. to install this new instrument, which will help keep up with the growing demand for testing.

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Source: Abbott
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