21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(a) Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
(b) Classification. Class II.
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