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e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter HPart 862Subpart D → §862.3850


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems


§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]

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