21 CFR 862.3680 — Radioimmunoassay, Primidone
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3680
Identification
A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DIL | Radioimmunoassay, Primidone | 2 | 0 | 3rd Party |
| DJD | Enzyme Immunoassay, Primidone | 2 | 8 | 3rd Party |
| DMQ | Gas Chromatography, Primidone | 2 | 0 | 3rd Party |
| DOS | Thin Layer Chromatography, Primidone | 2 | 0 | 3rd Party |
| DPQ | Liquid Chromatography, Primidone | 2 | 0 | 3rd Party |
| LCZ | U.V. Spectrometry, Primidone | 2 | 0 | 3rd Party |
| LFT | Fluorescent Immunoassay, Primidone | 2 | 8 | 3rd Party |
