Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 866  /  Sec. 866.5210 Ceruloplasmin immunolog ical test system.

(a) Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper- transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

(b) Classification. Class II (performance standards).