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NEW YORK (360Dx) – Thermo Fisher Scientific received 510(k) clearance from the US Food and Drug Administration last month for its assay for assessing patients suspected of having sepsis, one of a number of diagnostic tests that the agency cleared for marketing in June.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.