← Product Code [DIC](/productcode/DIC) · K913125

# ROCHE REAGENT FOR ETHANOL (K913125)

_Roche Diagnostic Systems, Inc. · DIC · Aug 12, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K913125

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [DIC](/productcode/DIC.md)
- **Decision Date:** Aug 12, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3040
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

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**Source:** [https://fda-staging.innolitics.com/device/K913125](https://fda-staging.innolitics.com/device/K913125)

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