§ 862.3035. Amikacin test system.
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/us/cfr/t21/s§ 862.3035·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
(b)Classification. Class II.