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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5340


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§866.5340   Ferritin immunological test system.

(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).

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