21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(a) Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
(b) Classification. Class II.
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Federal Register documents that created or amended this section.