Abbott Afinion HbA1c Reagent Catridge - Pack of 15 (1116974)

The Abbott Afinion HbA1c Reagent Cartridge is an advanced in vitro diagnostic tool designed for the precise and efficient quantitative determination of glycated hemoglobin (HbA1c) levels in human whole blood. This reagent cartridge is specifically optimized for use with the Abbott Afinion 2 Analyzer and the Afinion AS100 Analyzer, providing reliable results for point-of-care settings. The measurement of HbA1c is crucial for monitoring long-term metabolic control in patients with diabetes mellitus, and the test also serves as an aid in the diagnosis of diabetes and in identifying individuals at risk of developing the condition.

Each Abbott Afinion HbA1c Reagent Cartridge, supplied in a "Pack of 15", contains all necessary reagents for a single test and features an integrated sampling device for easy collection of 1.5 µL of whole blood. The cartridges are designed for stability, requiring refrigeration at 2-8°C in sealed foil pouches until their expiry date. For convenience, unopened foil pouches can be stored at room temperature (15-25°C) for up to 90 days.

The Afinion HbA1c Dx assay has received clearance from the U.S. Food and Drug Administration (FDA) for both monitoring and diagnosis of diabetes mellitus, as well as for assessing the risk of developing the disease. It is also certified by NGSP and IFCC, ensuring comparability with laboratory methods. In the UK, the device is regulated as an in vitro diagnostic (IVD) medical device under the UK Medical Devices Regulations 2002.

Key Features : 

Quantitative determination of glycated hemoglobin (HbA1c) in human whole blood for diabetes monitoring and diagnosis
Compatible with Abbott Afinion 2 Analyzer and Afinion AS100 Analyzer platforms
Store refrigerated at 2-8°C until expiry date, or at room temperature (15-25°C) for up to 90 days in unopened foil pouches
FDA cleared for diagnosis and monitoring, NGSP and IFCC certified, and MHRA regulated in the UK