Device Dossier
Hepatitis B virus IVDs
Device Dossier for Hepatitis B virus IVDs (CT704 - Hepatitis B virus IVDs, Class 3, sponsor Siemens Healthcare). ARTG record, intended purpose, GMDN…
- GMDN category: CT704 - Hepatitis B virus IVDs
Intended purpose
In vitro diagnostic use in the quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma that are confirmed positive for HBsAg. Measurements of hepatitis B surface antigen (HBsAg) are used as an aid in the management of hepatitis B virus (HBV) infection.