SEA — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users Class II
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 |