21 CFR 866.5510
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.5510, § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89645
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Full text
(a) Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.