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FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
On Mar. 21, 2020, the FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories, as well as in certain patient care settings.
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Source: U.S. Food & Drug Administration
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