Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2660](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2660) → MJM — Dna Probe, Gardnerella Vaginalis

# MJM · Dna Probe, Gardnerella Vaginalis

_Microbiology · 21 CFR 866.2660 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MJM

## Overview

- **Product Code:** MJM
- **Device Name:** Dna Probe, Gardnerella Vaginalis
- **Regulation:** [21 CFR 866.2660](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2660)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964015](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MJM/K964015.md) | INDICARD TEST | Litmus Concepts, Inc. | Jun 19, 1997 | SESE |
| [K923133](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MJM/K923133.md) | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | Microprobe Corp. | Sep 25, 1992 | SESE |

## Top Applicants

- Litmus Concepts, Inc. — 1 clearance
- Microprobe Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MJM](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MJM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com