HbA1c-CHECK-1 Quantitative determination of glycated haemoglobin in whole blood samples

The HbA1c-CHECK-1 rapid test is intended for the quantitative determination of glycated haemoglobin in human whole blood samples to be used as an aid for medical healthcare professionals to assess glucose metabolism disorders such as diabetes. The sole determination of concentration in HbA1c is not sufficient to diagnose diabetes or complications due to abnormal levels in glycated haemoglobin. In addition, the HbA1c-CHECK-1 test result should not be used to adapt or modify the treatment of patients suffering from diabetes.

Each kit contains

1. HbA1c-CHECK-1 aluminium pouch 10 20 containing: - 1 test device - 1 disposable capillary pipette (20 µL)
2. Plastic dropper bottle containing lysing reagent: 10 20
3. Leaflet: 1 1
4. Controls (Optional): Positive control (ref. V9600) and Negative control (ref. V9601): a freeze-dried preparation of a non-infectious compound in diluted human serum, tested and found negative for anti-HIV, anti-HCV and HBs antigen, containing 0.05 % sodium azide is optionally available as a positive and negative control (1x 0.50 mL). The concentration range is indicated on the vial label.