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HemoCue Point-of-Care Hemoglobin Test System Cleared by FDA

NEW YORK (360Dx) – HemoCue announced today its HemoCue Hb 801 System has received 510(k) clearance from the US Food and Drug Administration for marketing.

The platform enables healthcare providers to assess the hemoglobin levels of patients at the point of care in a clinic and quantitatively measures hemoglobin in capillary or venous whole blood. It is intended for use on adults, adolescents, children, and infants older than one month of age.

The HemoCue Hb 801 System comprises an analyzer and microcuvettes and is CLIA-waived, said HemoCue, which is based in Sweden.

"The advancements of our HemoCue Hb 801 Syhstem, combined with our comprehensive service offering, enable point-of-care hemoglobin testing to fit seamlessly into a clinic's daily workflow," HemoCue America interim General Manager Chris Mueller said in a statement.