§ 862.3880. Theophylline test system.
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/us/cfr/t21/s§ 862.3880·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
(b)Classification. Class II.