Device typeInherited haemoglobinopathy IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.
FDA categorySYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN
Device IDM5255519770
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information