Device Dossier
Multiple clinical chemistry constituent IVDs
Device Dossier for Multiple clinical chemistry constituent IVDs (CT889 - Multiple clinical chemistry constituent IVDs, Class 2, sponsor Australian…
- GMDN category: CT889 - Multiple clinical chemistry constituent IVDs
Intended purpose
CT889 Multiple clinical chemistry constituent IVDs ASE controls are intended to monitor the performance of laboratory testing procedures for the analytes listed in the package insert. Multiple levels of control are available to allow performance monitoring.The IVDs are intended to be used for the qualitative and/or quantitative determination of multiple analytes.