# Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay
> **Food and Drug Administration** · Final order. · Published 2015-11-02 · Effective 2015-11-02 · 80 FR 67313
## Document
- **Document number:** 2015-27817
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 67313
- **CFR reference:** 21 CFR 866
- **Publication date:** 2015-11-02
- **Effective date:** 2015-11-02
- **HHS docket:** Docket No. FDA-2015-N-3392
## Abstract

The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based 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/2015/11/02/2015-27817/medical-devices-immunology-and-microbiology-devices-classification-of-gastrointestinal-microorganism)
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