Device Dossier
Cytomegalovirus (Human herpesvirus 5) IVDs
Device Dossier for Cytomegalovirus (Human herpesvirus 5) IVDs (CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs, Class 3, sponsor Werfen). ARTG record,…
- GMDN category: CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs
Intended purpose
Fully automated chemiluminescent two step immunoassay intended to be used for the quantitative measurement of antibodies in human serum or plasma to provide information about infection with or exposure to Cytomegalovirus (CMV), also referred to as Human herpesvirus 5.