21 CFR 862.3040 — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3040
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 2 | 33 | 3rd Party |
| DIZ | Delayed Analysis, Alcohol | 2 | 0 | 3rd Party |
| DLA | Test Reagents For Methyl Alcohol | 2 | 0 | 3rd Party |
| DLH | Gas Chromatography, Alcohol | 2 | 0 | 3rd Party |
| DLS | Gas Chromatograph, Alcohol (Dedicated Instruments) | 2 | 0 | 3rd Party |
| DMI | Potassium Dichromate Specific Reagent For Alcohol | 2 | 1 | 3rd Party |
| DMJ | Test Reagents For Ethyl Alcohol | 2 | 0 | 3rd Party |
| DML | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method | 2 | 13 | 3rd Party |
| DMT | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | 2 | 8 | 3rd Party |
| DOJ | Potassium Dichromate, Alcohol | 2 | 2 | 3rd Party |
| OIC | Blood Alcohol Kit (Excludes Hiv Testing) | 2 | 0 | |
| ORA | Breast Milk-Alcohol Test System | 2 | 0 |
