21 CFR § 862.3850 - Sulfonamide test system.

§ 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.

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