Device Dossier

Epstein-Barr virus (Human herpesvirus 4) IVDs

Device Dossier for Epstein-Barr virus (Human herpesvirus 4) IVDs (CT747 - Epstein-Barr virus (Human herpesvirus 4) IVDs, Class 3, sponsor Abbott…

Intended purpose

The Abbott EBV assay is an in vitro polymerase chain reaction (PCR) assay to quantitate Epstein-Barr Virus (EBV) DNA in human EDTA plasma. The assay is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients.

TGA Public Summary