# Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay
> **Food and Drug Administration** · Final order. · Published 2015-08-27 · Effective 2015-09-28 · 80 FR 51938
## Document
- **Document number:** 2015-21237
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 51938
- **CFR reference:** 21 CFR 866
- **Publication date:** 2015-08-27
- **Effective date:** 2015-09-28
- **HHS docket:** Docket No. FDA-2015-N-2963
## Abstract

The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2015/08/27/2015-21237/medical-devices-immunology-and-microbiology-devices-classification-of-clostridium-difficile-toxin)
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