DIL · Radioimmunoassay, Primidone
Clinical Toxicology · 21 CFR 862.3680 · Class 2
Overview
| Product Code | DIL |
|---|---|
| Device Name | Radioimmunoassay, Primidone |
| Regulation | 21 CFR 862.3680 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
