18 devices · GMDN 55900
This category includes reagents used in laboratory tests to measure the amount of fetal haemoglobin (HbF) in blood samples. These substances are designed to work with specific diagnostic instruments to detect and quantify HbF, which is important for assessing conditions like thalassemia, sickle cell disease, and hereditary persistence of fetal haemoglobin.
As in vitro diagnostic (IVD) reagents, these products are intended for use only in professional healthcare settings and are regulated based on their role in supporting diagnostic testing. They are not standalone tests but are components that enable the measurement of HbF when used with compatible IVD systems, and their regulatory status depends on the overall assay they support.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.