DLS · Gas Chromatograph, Alcohol (Dedicated Instruments)
Clinical Toxicology · 21 CFR 862.3040 · Class 2
Overview
| Product Code | DLS |
|---|---|
| Device Name | Gas Chromatograph, Alcohol (Dedicated Instruments) |
| Regulation | 21 CFR 862.3040 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
