Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 862  /  Sec. 862.1410 Iron (non-heme) test system.

(a) Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

(b) Classification. Class I.