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52 FR 16122, May 1, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 862.3950
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(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.