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NEW YORK – Chembio Diagnostics announced Monday its DPP Zika IgM System, which includes the DPP Zika IgM Assay and DPP Micro Reader, has received 510(k) clearance from the US Food and Drug Administration.

The system is meant to detect Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens within 15 minutes. Patients must meet the Zika virus clinical or epidemiological criteria from the US Centers for Disease Control and Prevention in order to be tested.

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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.