LDA · U.V. Spectrometry, Phenobarbital
Clinical Toxicology · 21 CFR 862.3660 · Class 2
Overview
| Product Code | LDA |
|---|---|
| Device Name | U.V. Spectrometry, Phenobarbital |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
