---
kind: "section"
citation: "21 C.F.R. § 866.5160"
title: "21"
number: "866.5160"
heading: "Beta -globulin immunological test system."
url: "https://uscodex.org/cfr/21/866.5160"
---

# §866.5160. Beta -globulin immunological test system.

- (a) **Identification.** A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 866.9](/cfr/21/866.9.md).

## Notes

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

### 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.

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]