21 CFR 866.5580
§ 866.5580
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5580, § 866.5580, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89652
- Permanent ID
ys:prov:89652@1- SHA-256
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Full text
(a) Identification. An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
(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.