Device Category Dossier

CT747 - Epstein-Barr virus (Human herpesvirus 4) IVDs

Device Category Dossier for CT747 - Epstein-Barr virus (Human herpesvirus 4) IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Epstein-Barr virus in vitro diagnostic devices use quantitative nucleic acid real-time PCR assays to detect and quantify EBV DNA extracted from clinical specimens. These devices are used as an aid in the diagnosis and management of EBV infection in transplant patients and other immunocompromised patients.