Device Dossier
Mycobacteria IVDs
Device Dossier for Mycobacteria IVDs (CT791 - Mycobacteria IVDs, Class 3, sponsor Abbott Australasia Pty Ltd - Rapid Diagnostics Division). ARTG record,…
- GMDN category: CT791 - Mycobacteria IVDs
Intended purpose
The Bioline™ TB Ag MPT64 is a rapid immunochromatographic identification test for the M.tuberculosis complex that uses mouse monoclonal anti-MPT64. The test kit can be easily used for rapid identification of the M.tuberculosis complex in combination with culture systems based on liquid media without any technical complexity in clinical laboratories.