AxSYM AUSAB Reagent Kit, Calibrator and Controls The device is
AxSYM AUSAB Reagent Kit, Calibrator and Controls
The device is a lab test used to determine whether a person is, or has been, infected with the hepatitis B virus (HBV), or to determine whether a patient needs to be vaccinated with HBV vaccine. (Approved: 8/7/2006)