Ceruloplasmin immunological test system.

§866.5210
Ceruloplasmin immunological test system.
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.
Classification. Class II (performance standards).