21 CFR 862.3910 - Tricyclic antidepressant drugs test system.

§ 862.3910 Tricyclic antidepressant drugs test system.

(a)Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

(b)Classification. Class II.

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United States Code