21 CFR 862.3660 — Thin Layer Chromatography, Phenobarbital
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3660
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DIX | Thin Layer Chromatography, Phenobarbital | 2 | 0 | 3rd Party |
| DJH | Gas Chromatography, Phenobarbital | 2 | 1 | 3rd Party |
| DKP | Radioimmunoassay, Phenobarbital | 2 | 3 | 3rd Party |
| DLZ | Enzyme Immunoassay, Phenobarbital | 2 | 35 | 3rd Party |
| DOO | Liquid Chromatography, Phenobarbital | 2 | 0 | 3rd Party |
| LDA | U.V. Spectrometry, Phenobarbital | 2 | 0 | 3rd Party |
| LET | Fluorescent Immunoassay, Phenobarbital | 2 | 8 | 3rd Party |
| LFN | Nephelometric Inhibition Immunoassay, Phenobarbital | 2 | 5 | 3rd Party |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 2 | 12 | 3rd Party |
