21 C.F.R. § 866.5340

Ferritin immunological test system.

Last amended: 2016Year: 2026Length: 59 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 866.5340 (2026)

(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).
21 C.F.R. § 866.5340: Ferritin immunological test system. | Justis AI