Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1700](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1700) → MJE — Culture Media, Antifungal, Susceptibility Test

# MJE · Culture Media, Antifungal, Susceptibility Test

_Microbiology · 21 CFR 866.1700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MJE

## Overview

- **Product Code:** MJE
- **Device Name:** Culture Media, Antifungal, Susceptibility Test
- **Regulation:** [21 CFR 866.1700](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1700)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K072827](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MJE/K072827.md) | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | Remel, Inc. | Nov 26, 2007 | SESE |

## Top Applicants

- Remel, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MJE](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MJE)

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