# Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens
> **Food and Drug Administration** · Final order. · Published 2017-01-12 · Effective 2017-02-13 · 82 FR 3609
## Document
- **Document number:** 2017-00199
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 3609
- **CFR reference:** 21 CFR 866
- **Publication date:** 2017-01-12
- **Effective date:** 2017-02-13
- **HHS docket:** Docket No. FDA-2014-N-0440
## Abstract

The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for)
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