FDA Class 2
Athelas has conducted clinical studies meant to show equivalence to the FDA Class 2 predicates in the field of Cell counting - these are currently under evaluation by the FDA. Further at-home studies are being conducted for OTC designation.
Precision and Accuracy
We take accuracy and transparency seriously. Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex 500.