21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices

§ 862.3850 Sulfonamide test system

Subpart D - Clinical Toxicology Test Systems Official text on eCFR Amendment history

(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.

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Amendment history

Federal Register documents that created or amended this section.