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Title 21 → Chapter I → Subchapter H → Part 862 → Subpart D → §862.3660 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems
§862.3660 Phenobarbital test system.
(a) Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
(b) Classification. Class II.