HORIBA's Yumizen H550 Hematology Analyzer gains FDA 510(k) clearance
HORIBA's Yumizen H550 hematology analyzer has gained FDA 510(k) clearance, enabling its use in clinical laboratories for detailed blood analysis, including CBC and WBC differentials.
HORIBA announced the Yumizen H550 Hematology Analyzer has received U.S. Food and Drug Administration (FDA) 510(k) clearance for in vitro diagnostic use in clinical laboratories.
The Yumizen H550 is intended for the analysis of venous and capillary whole blood samples and is designed to assist laboratories in the screening of physiological and pathological samples through the detection of quantitative and qualitative hematological abnormalities. The analyzer provides comprehensive hematology information that can aid healthcare professionals in evaluating patient populations encountered in routine clinical laboratory settings.
Key features of the Yumizen H550 include:
Complete Blood Count (CBC) analysis
6-part White Blood Cell differential, including Immature Granulocyte (IMG) enumeration
Testing capabilities for adult and pediatric patient populations
Compatibility with venous and capillary whole blood samples
In vitro diagnostic use in clinical laboratory environments
