← Product Code [LLH](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH) · K913229

# BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN (K913229)

_Baxter Diagnostics, Inc. · LLH · Aug 29, 1991 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K913229

## Device Facts

- **Applicant:** Baxter Diagnostics, Inc.
- **Product Code:** [LLH](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH.md)
- **Decision Date:** Aug 29, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2660
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K913229](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K913229)

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