Device Dossier
Haemoglobin IVDs
Device Dossier for Haemoglobin IVDs (CT880 - Haemoglobin IVDs, Class 2, sponsor Helena Laboratories). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT880 - Haemoglobin IVDs
Intended purpose
The glycated haemoglobin (HbA1c) Assay Kit is used together with the HbA1c analyser produced by Shanghai Medconn Technology Co., Ltd. intended for the percent determination of HbA1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The glycated haemoglobin (HbA1c) Column is used together with the glycated haemoglobin Assay Kit to measure HbA1c in human whole blood using HPLC. The HbA1c Haemolyser is used for pre treatment of blood samples for HbA1c test.