Wako Diagnostics was issued three class III medical device licenses by Health Canada to market the uTAS-Wako i30 instrument with the serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) for clinical use in Canada. The AFP-L3 and DCP tests are intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma.
The uTASWako i30 benchtop instrument features automated calibration and quality control and requires minimal setup. The first test result is delivered in nine minutes, with subsequent results two minutes apart. Reagent usage is tracked with radio-frequency identification tags.
Wako Diagnostics, 877-714-1924