Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Bio-Rad Laboratories). ARTG record,…

GMDN category: CT353 - Bacterial infectious disease IVDs

Intended purpose

IVD unassayed controls intended to be used with specific molecular assays to monitor the performance of that given assay. Routine use of these controls allows laboratories to evaluate daily of their molecular assays and proficiency.

TGA Public Summary