21 CFR 866.5530
§ 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5530, § 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89647
- Permanent ID
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Full text
(a) Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.
(b) Classification. Class I (general 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.