# Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents
> **Food and Drug Administration** · Final rule. · Published 2012-03-09 · Effective 2012-04-09 · 77 FR 14272
## Document
- **Document number:** 2012-5675
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 77 FR 14272
- **CFR reference:** 21 CFR 866
- **Publication date:** 2012-03-09
- **Effective date:** 2012-04-09
- **HHS docket:** Docket No. FDA-2012-N-0165
## Abstract

The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Class II Special Controls Guidance Document: Norovirus Serological Reagents." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2012/03/09/2012-5675/medical-devices-immunology-and-microbiology-devices-classification-of-norovirus-serological-reagents)
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