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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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