# Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis Nucleic Acid Assay
> **Food and Drug Administration** · Final order. · Published 2015-08-04 · Effective 2015-08-04 · 80 FR 46190
## Document
- **Document number:** 2015-19072
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 46190
- **CFR reference:** 21 CFR 866
- **Publication date:** 2015-08-04
- **Effective date:** 2015-08-04
- **HHS docket:** Docket No. FDA-2015-N-2526
## Abstract

The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid 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/2015/08/04/2015-19072/medical-devices-immunology-and-microbiology-devices-classification-of-trichomonas-vaginalis-nucleic)
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