GroundRules
21 CFR 862.3850: Sulfonamide test system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
- Subpart D—Clinical Toxicology Test Systems
(a) 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.
(b) Classification. Class I.
Collected 2026-08-27T02:24:47Z. Source file · JSON