Hemoglobin testing company HemoCue reported on Wednesday the receipt of the Food and Drug Administration's (FDA) 510(k) clearance of the new HemoCue Hb 801 System test that enables healthcare providers to assess patients' hemoglobin levels while present in their clinics.

Headquartered in Ängelholm, Sweden, the company has now launched the HemoCue Hb 801 System to physician lab offices across the US with immediate effect.

The company said the HemoCue Hb 801 System quantitatively measures hemoglobin in capillary or venous whole blood and is for professional in vitro diagnostic use only. It is intended to be used to determine the hemoglobin concentration for adults, adolescents, children and infants above one month old.

According to the company, the HemoCue Hb 801 System consists of an analyser together with microcuvettes, CLIA-waived, seamlessly integrates into the daily clinic operation, large display, intuitive on-screen symbols, results under one second, internal quality control self-test, reagent-free cuvettes, improving open-vial stability, bluetooth wireless capability as well as no preventative maintenance.

In addition, the company provides a best-in-class comprehensive offering, extensive in-field support from a HemoCue representative, complementary, comprehensive on-site or online product training programmes as well as live customer service and technical support.