For in vitro diagnostic use. Others LumiraDx HbA1c IVD LumiraDx HbA1c PID00000890 10 443 022 001 10443022001 LumiraDx HbA1c Test (24T) ML03 LumiraDx HbA1c Test (24T) ML03 05060537714561 Reagents, kits L006000104024 24 tests Not Available undefined 10 418 109 001 10418109001 LumiraDx HbA1c Test (24T) ML01 LumiraDx HbA1c Test (24T) ML01 05060537714530 Reagents, kits L006000101024 24 tests Not Available undefined LumiraDx HbA1c es un test de diagnóstico in vitro para la determinación cuantitativa de la hemoglobina A1c (IFCC mmol/mol y NGSP %) en muestras de sangre completa capilar y venosa (EDTA) humana. Las Tiras Reactivas LumiraDx HbA1c están indicadas para utilizarse con el LumiraDx Instrument. Es un test diagnóstico in vitro para pruebas en puntos de atención. La HbA1c se utiliza para vigilar el control de la glucemia a largo plazo en personas con diabetes mellitus, y como una ayuda para el cribado y la identificación de pacientes con posible riesgo de desarrollar diabetes. El test LumiraDx HbA1c es para uso profesional exclusivamente. Para pacientes ≥2 años de edad. es 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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LumiraDx HbA1c

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