Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3680](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3680) → DOS — Thin Layer Chromatography, Primidone

# DOS · Thin Layer Chromatography, Primidone

_Clinical Toxicology · 21 CFR 862.3680 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOS

## Overview

- **Product Code:** DOS
- **Device Name:** Thin Layer Chromatography, Primidone
- **Regulation:** [21 CFR 862.3680](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3680)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOS](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOS)

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