Device Dossier
Hepatitis E virus IVDs
Device Dossier for Hepatitis E virus IVDs (CT707 - Hepatitis E virus IVDs, Class 3, sponsor DiaSorin). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT707 - Hepatitis E virus IVDs
Intended purpose
IVDs that use chemiluminescence Immunoassay (CLIA) technology for the determination of specific antibodies to hepatitis E virus in human serum or plasma. IVDs intended as an aid in the diagnosis of HEV infection in individuals with or without symptoms of hepatitis.