HemoCue HbA1c 501 TestCart, BOX/10

General Description:
HemoCue HbA1c 501 Test Cartridges BOX of 10 tests.

Intended use:
The HemoCue HbA1c 501 test cartridge is intended for use on the HemoCue HbA1c 501 Analyzer only. HemoCue HbA1c 501 test cartridge is intended for the quantitative determination of glycated haemoglobin (HbA1c) in capillary, and anticoagulated venous whole blood to monitor glycaemic control in patients with diabetes mellitus.

Technical Specifications
·Assay Principle: Boronate affinity assay to separate the glycated haemoglobin fraction from the non-glycated fraction.
·Dedicated single-use test cartridges, individually wrapped.
·Sample type: Capillary or venous blood.
·Sample volume: 4µL.

· Compatibility: Only for use with the HemoCue HbA1c 501 analyzer.

Supplier’s product reference:
405110

QMS/Regulatory information:
· CE-IVD.
· ISO 13485: 2016.

Item supplied with:
10 x HemoCue HbA1c Cartridges
1 x IFU

Item Required but not provided:
HemoCue HbA1c 501 analyser (Separately ordered).

Shelf life:
18 months

Storage & transportation Conditions:
2 to 32 °C.

Weight and Volume:
Estimated weight: 0.3460kg.
Estimated volume: 0.0028 dm³.

Packaging and Labelling:
Unit presentation: HemoCue HbA1c 501 Test Cartridges, box of 10 tests.