DKW · Test Reagents For Sulphanimide Derivatives
Clinical Toxicology · 21 CFR 862.3850 · Class 1
Overview
| Product Code | DKW |
|---|---|
| Device Name | Test Reagents For Sulphanimide Derivatives |
| Regulation | 21 CFR 862.3850 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
