Device Category Dossier

CT707 - Hepatitis E virus IVDs

Device Category Dossier for CT707 - Hepatitis E virus IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Hepatitis

E virus in vitro diagnostic devices use chemiluminescence immunoassay or enzyme immunoassay technology to detect specific antibodies to hepatitis E virus in human serum or plasma. These devices are intended as an aid in the diagnosis of hepatitis E virus infection in individuals with or without symptoms of hepatitis.