The LumiraDx HbA1c test is an in vitro diagnostic test for the quantitative determination of hemoglobin 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 Instrument. It is an automated in vitro diagnostic test for near-patient testing. HbA1c is used for the monitoring of long-term glycaemic control in individuals with diabetes mellitus, and as an aid in screening and identifying patients who may be at risk for developing diabetes.

* Microfluidic immunofluorescence assay
* Sample types: capillary fingerstick or venous whole blood (EDTA) via lysis device
* Sample size: 15uL
* Time to result: < 7 minutes
* Storage at room temperature