21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(a) Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
(b) Classification. Class II.
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Federal Register documents that created or amended this section.