---
kind: "section"
citation: "21 C.F.R. § 866.5580"
title: "21"
number: "866.5580"
heading: "Alpha -1-lipoprotein immunological test system."
url: "https://uscodex.org/cfr/21/866.5580"
---

# §866.5580. Alpha -1-lipoprotein immunological test system.

- (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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.