21 C.F.R. § 866.5340 Ferritin immunological test system.
Title 21 - Food and Drugs
(a) Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5340 Ferritin immunological test system.
