De Novo DEN230090
- Device
- First To Know Syphilis Test
- Contact
- kevin clark
- De Novo number
- DEN230090
- Product code
- SBZ
- Regulation
- 866.3986
- Classification name
- test for detection of antibodies associated with syphilis performed by lay users
- Decision
- granted (DENG)
- Decision date
- 2024-08-16
- Date received
- 2023-12-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SBZ
- Device name
- Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3986
- Implant
- N
- Life sustain/support
- N