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NEW YORK – Ortho Clinical Diagnostics announced Monday its Vitros BRAHMS procalcitonin assay to identify bacterial infections received 510(k) clearance from the US Food and Drug Administration.

The assay will be available on the Vitros 3600 Immunodiagnostic System, Vitros 5600 and Vitros XT 7600 Integrated Systems, and Vitros ECi/ECiQ Systems. It can help with early detection of severe bacterial infections, including sepsis, acute bronchitis, and community-acquired pneumonia, the company said.

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Oct
09
Sponsored by
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.