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The LumiraDx HbA1c test is an in vitro diagnostic test for the quantitative determination of haemoglobin A1c (IFCC mmol/mol and NGSP %) in human capillary and venous whole blood samples (EDTA). The LumiraDx HbA1c test strips are intended for use with the LumiraDx device. HbA1c is used to monitor long-term blood glucose control in people with diabetes mellitus and supports the screening and identification of patients at risk of diabetes. For patients 2 years and older.