---
kind: "section"
citation: "21 C.F.R. § 862.1335"
title: "21"
number: "862.1335"
heading: "Glucagon test system."
url: "https://uscodex.org/cfr/21/862.1335"
---

# §862.1335. Glucagon test system.

- (a) **Identification.** A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.
- (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 [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

### Authority

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

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]