Device Dossier
Interpretive software IVDs
Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 2, sponsor Copan). ARTG record, intended purpose, GMDN category…
- GMDN category: CT910 - Interpretive software IVDs
Intended purpose
SOFTWARE HALO MEASURE & VISUAL is a WASPLab® software optional module intended for the automatic detection of inhibition haloes on images of culture media plates prepared for Antimicrobial Susceptibility Testing. Radian® Expert System is a WASPLab® software optional module intended for interpretation of the inhibition zone diameters and MIC values provided by SOFTWARE HALO MEASURE & VISUAL for clinical Susceptibility/Intermediate/Resistant (SIR) categorizations.