21 CFR 862.3850 — Test Reagents For Sulphanimide Derivatives
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3850
Identification
A sulfonamide test system is a device intended to measure sulfonamides, any of the antibacterial drugs derived from sulfanilamide, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of sulfonamide overdose and in monitoring sulfonamide levels to ensure appropriate therapy.
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DKW | Test Reagents For Sulphanimide Derivatives | 1 | 0 | 3rd Party |
