21 CFR 862.3560 — Flame Photometry, Lithium
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3560
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).
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JIH | Flame Photometry, Lithium | 2 | 12 | 3rd Party |
| JII | Atomic Absorption, Lithium | 2 | 3 | 3rd Party |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 2 | 7 | 3rd Party |
