De Novo DEN240020
- Device
- Visby Medical Women's Sexual Health Test
- Contact
- jennifer albrecht
- De Novo number
- DEN240020
- Product code
- SEA
- Regulation
- 866.3386
- Classification name
- test for detection of microorganism(s) causing sexually transmitted infections performed by lay users
- Decision
- granted (DENG)
- Decision date
- 2025-03-28
- Date received
- 2024-05-13
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SEA
- Device name
- Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3386
- Implant
- N
- Life sustain/support
- N