# Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device
> **Food and Drug Administration** · Final rule. · Published 2011-08-09 · Effective 2011-09-08 · 76 FR 48715
## Document
- **Document number:** 2011-20115
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 48715
- **CFR reference:** 21 CFR 866
- **Publication date:** 2011-08-09
- **Effective date:** 2011-09-08
- **HHS docket:** Docket No. FDA-2010-N-0429
## Abstract

The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/08/09/2011-20115/immunology-and-microbiology-devices-reclassification-of-the-herpes-simplex-virus-serological-assay)
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