21 C.F.R. § 862.3850

Current through November 30, 2024
Section 862.3850 - Sulfonamide test system
(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.

21 C.F.R. §862.3850

52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310 , Jan. 14, 2000