Device typeGlycated haemoglobin (HbA1C) analyser IVD: A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).
FDA categoryINSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY
Device ID03610522126750
Catalog number12010405
MRI safetyLabeling does not contain MRI Safety Information
Size1 each