Device Dossier

Antimicrobial susceptibility testing IVDs

Device Dossier for Antimicrobial susceptibility testing IVDs (CT1260 - Antimicrobial susceptibility testing IVDs, Class 2, sponsor Advanced Biotech).…

Intended purpose

The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial agent that inhibits the visible growth of a microorganism. Four types of gradient test strips are available for MIC determination, each designed to identify the minimum concentration of their respective agents that inhibits microbial growth: BMIC™ for antibacterial MIC testing, FMIC™ for antifungal MIC testing, RMIC™ for detection of resistance mechanisms through MIC determination, and TMIC™ for antituberculosis MIC testing.

TGA Public Summary