21 CFR 862.3830 — Gas Chromatography, Salicylate
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3830
Identification
A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DIM | Gas Chromatography, Salicylate | 2 | 0 | 3rd Party |
| DJE | Thin Layer Chromatography, Salicylate | 2 | 1 | 3rd Party |
| DKJ | Colorimetry, Salicylate | 2 | 29 | 3rd Party |
| DMX | Liquid Chromatography, Salicylate | 2 | 0 | 3rd Party |
| DNC | Strip, Paper, Salicylate | 2 | 0 | 3rd Party |