SEA · Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Microbiology · 21 CFR 866.3386 · Class 2
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 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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 | Visby Medical Women's Sexual Health Test | Visby Medical, Inc. | Mar 28, 2025 | DENG |
Top Applicants
- Visby Medical, Inc. — 1 clearance
