Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) → CHR — Titrimetric Phenol Red, Carbon-Dioxide

# CHR · Titrimetric Phenol Red, Carbon-Dioxide

_Clinical Chemistry · 21 CFR 862.1160 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHR

## Overview

- **Product Code:** CHR
- **Device Name:** Titrimetric Phenol Red, Carbon-Dioxide
- **Regulation:** [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHR](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHR)

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