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NEW YORK (360Dx) – Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration has granted 510(k) clearance for its Gem Premier ChemStat in vitro diagnostic analyzer incorporating its Intelligent Quality Management module.  

The system is designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital emergency departments and clinical laboratories, IL said.

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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.