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NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in October from Siemens Healthineers, Thermo Fisher Scientific, DiaSorin, Microbiologics, and others, according to the agency's website.

Siemens Healthineers received clearance for the Atellica IM Total hCG assay for the quantitative measurement of human chorionic gonadotropin in human serum or plasma, using the firm's Atellica IM Analyzer. Human chorionic gonadotropin measurements are used to detect pregnancy.

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Oct
09
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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.