TDXR REA(TM) ETHANOL
Device Facts
| Record ID | K871645 |
|---|---|
| Device Name | TDXR REA(TM) ETHANOL |
| Applicant | Abbott Laboratories |
| Product Code | DIC · Clinical Toxicology |
| Decision Date | Jun 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3040 |
| Device Class | Class 2 |
Regulatory Classification
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.
