---
kind: "section"
citation: "21 C.F.R. § 862.1160"
title: "21"
number: "862.1160"
heading: "Bicarbonate/carbon dioxide test system."
url: "https://uscodex.org/cfr/21/862.1160"
---

# §862.1160. Bicarbonate/carbon dioxide test system.

- (a) **Identification.** A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
- (b) **Classification.** Class II.

## Notes

### 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.