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NEW YORK (360Dx) – EKF Diagnostics Holdings said today that the US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver for use of its hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, in point-of-care settings.

The test provides users with accurate hemoglobin measurements within two seconds of the microcuvette being placed into the analyzer, EKF said, adding that the analyzer is palm-sized, easy to transport, and battery operated for remote use.

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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.