Electronic Code of Federal Regulations
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e-CFR data is current as of July 6, 2020 |
Title 21 → Chapter I → Subchapter H → Part 866 → Subpart F → §866.5210 |
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§866.5210 Ceruloplasmin immunological 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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]