SEA — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users Class II
FDA product code SEA covers "Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users", a Class II medical device regulated under 21 CFR 866.3386. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEA
- Device Class
- Class II
- Regulation Number
- 866.3386
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240020 | visby medical | Visby Medical Women's Sexual Health Test | March 28, 2025 |