Danaher’s point-of-care focused HemoCue subsidiary has launched its newest hemoglobin test in the U.S. following a recent 510(k) clearance from the FDA.
The company’s Hb 801 system allows healthcare providers to quickly assess a patient’s hemoglobin levels and detect anemia while they wait, during a single clinic visit.
"Our tests make it easy for clinicians to get a lab-quality result while the patient is present, which allows for more engagement in the overall healthcare process,” HemoCue President Christophe Duret said in a statement.
The in vitro diagnostic system—consisting of a CLIA-waived analyzer and its own set of small, reagent-free, clear blood containers—measures hemoglobin counts in capillary or venous whole blood, and is intended for use in patients at least one month old.
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"With more than 35 years in point-of-care testing, we understand the everyday challenges to ensure a smooth-running clinic as critical to patient care," said Chris Mueller, interim general manager of HemoCue America.
"The advancements of our HemoCue Hb 801 System, combined with our comprehensive service offering, enable point-of-care hemoglobin testing to fit seamlessly into a clinic's daily workflow,” Mueller added.