Device Dossier

Mycobacteria IVDs

Device Dossier for Mycobacteria IVDs (CT791 - Mycobacteria IVDs, Class 3, sponsor Becton Dickinson). ARTG record, intended purpose, GMDN category —…

Intended purpose

Various IVD assays for the qualitative detection of Mycobacterium tuberculosis complex (MTBC) antigen. It will detect the following species: M. tuberculosis, M. bovis, M. africanum, M. microti, M. canettii, M. caprae and M. pinnipedii

TGA Public Summary