SEA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3386
- Medical specialty
- Microbiology
- FDA definition
- This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| Visby Medical Women's Sexual Health Test (DEN240020) | Visby Medical, Inc. | 2025-03-28 |
Track SEA automatically
Every clearance here is in the API, with alerts when new ones post.