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e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart D → §862.3560 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems
§862.3560 Lithium test system.
(a) Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
(b) Classification. Class II.