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 862.3450](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3450) → DJI — Antiserum, Gentamicin

# DJI · Antiserum, Gentamicin

_Clinical Toxicology · 21 CFR 862.3450 · Class 2_

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

## Overview

- **Product Code:** DJI
- **Device Name:** Antiserum, Gentamicin
- **Regulation:** [21 CFR 862.3450](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3450)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K812050](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJI/K812050.md) | KALLESTAD ANTISERA TO GENTAMICIN | Kallestad Laboratories, Inc. | Aug 3, 1981 | SESE |

## Top Applicants

- Kallestad Laboratories, Inc. — 1 clearance

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

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