Device Dossier

Cytomegalovirus (Human herpesvirus 5) IVDs

Device Dossier for Cytomegalovirus (Human herpesvirus 5) IVDs (CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs, Class 3, sponsor Beckman Coulter).…

GMDN category: CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs

Intended purpose

The Access CMV IgG/IgM assay is a paramagnetic-particle, chemiluminescent immunoassay for the semi-quantitative determination of IgG/ IgM antibodies to cytomegalovirus (CMV) in human serum and plasma (EDTA, heparin) using the Access Immunoassay Systems.

TGA Public Summary