21 CFR 862.3880 — Enzyme Immunoassay, Theophylline
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3880
Identification
A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | 2 | 71 | 3rd Party |
| LCA | Radioimmunoassay, Theophylline | 2 | 5 | 3rd Party |
| LCY | U.V. Spectrometry, Theophylline | 2 | 3 | 3rd Party |
| LER | Fluorescent Immunoassay, Theophylline | 2 | 15 | 3rd Party |
| LEW | Thin Layer Chromatography, Theophylline | 2 | 1 | 3rd Party |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 2 | 13 | 3rd Party |
