Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor ZIP Diagnostics). ARTG record, intended…

Intended purpose

IVD assay controls intended to be used with specific molecular assays to monitor the performance of that given assay. Routine use of these controls allows laboratories and point-of-care test operators to evaluate the assays performance.

TGA Public Summary