21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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.
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