CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES > SUBPART F—Immunological Test Systems (§866.5040 to §866.5910) > 866.5210—Ceruloplasmin immunolog-ical test system.

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).