§ 862.3450. Gentamicin test system.
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/us/cfr/t21/s§ 862.3450·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
(b)Classification. Class II.