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NEW YORK (360Dx) – Saladax Biomedical announced today it has submitted a de novo classification request to the US Food and Drug Administration for the MyCare Psychiatry Total Risperidone Assay Kit.

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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.