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NEW YORK (360Dx) – During May, the US Food and Drug Administration cleared in vitro diagnostic tests and systems from Siemens Healthineers, Roche Diagnostics, PerkinElmer, BioMérieux, and others, according to the agency's website.

Erlangen, Germany-based Siemens Healthineers received clearance for its Dimension Exl High-Sensitivity Troponin I Assay used to diagnose acute myocardial infarction running on its Dimension Exl integrated chemistry system.

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Oct
09
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PerkinElmer

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.