Device Dossier

Haematology calibrator/control IVDs

Device Dossier for Haematology calibrator/control IVDs (CT879 - Haematology calibrator/control IVDs, Class 2, sponsor Helena Laboratories). ARTG record,…

Intended purpose

Haemoglobin A1c Calibrator is intended for the calibration of the quantitative determination of the HbA1c, which is used in conjuction with the Haemoglobin Assay Kit produced by Shanghai Medconn Biotechnology Co.,Ltd. Haemoglobin A1c Control is intended for internal controls of HbA1c, which is used in conjunction with the Haemoglobin Assay Kit produced by Shanghai Medconn Biotechnology Co., Ltd. It is to verify the validity of the assay kit by measuring the quality controls within the known quality control range.

TGA Public Summary