For in vitro diagnostic use. Others LumiraDx HbA1c IVD LumiraDx HbA1c PID00000890 10 418 109 001 10418109001 LumiraDx HbA1c Test (24T) ML01 LumiraDx HbA1c Test (24T) ML01 05060537714530 Reagents, kits L006000101024 24 tests Not Available undefined 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. The LumiraDx HbA1c test is for Professional Use Only. For patients ≥2 years of age. en The LumiraDx HbA1c test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Instrument for the quantitative measurement of HbA1c in human capillary and venous whole blood. The test procedure involves the lysis of capillary or venous whole blood, followed by the addition of the hemolysate to the Sample Application Area of the Test Strip. The Instrument is programmed to perform the analysis when the sample has reacted with the reagents. The analysis is based on the amount of fluorescence the Instrument detects within the measurement area of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touch-screen approximately 7 minutes from sample addition. en

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