Device Dossier

Hepatitis E virus IVDs

Device Dossier for Hepatitis E virus IVDs (CT707 - Hepatitis E virus IVDs, Class 3, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN…

Intended purpose

For the in vitro quantitative and/or qualitative determination of Hepatitis E antibodies in human clinical samples to provide information about the status of infection

TGA Public Summary