Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3386](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3386) → SEA — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

# SEA · Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

_Microbiology · 21 CFR 866.3386 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEA

## Overview

- **Product Code:** SEA
- **Device Name:** Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- **Regulation:** [21 CFR 866.3386](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3386)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

The Visby Medical Women’s Sexual Health Test is a single-use (disposable), automated, rapid, compact device containing a PCR-based assay for the direct qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal swab specimens. It is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection.

## Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.3386, Test for detection of microorganism(s) causing sexually transmitted infections performed by lay users.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN240020](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEA/DEN240020.md) | Visby Medical Women's Sexual Health Test | Visby Medical, Inc. | Mar 28, 2025 | DENG |

## Top Applicants

- Visby Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEA)

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