De Novo DEN240035
- Device
- ConcizuTrace™ ELISA
- Contact
- karena shaw
- De Novo number
- DEN240035
- Product code
- SES
- Regulation
- 864.7298
- Classification name
- non-factor replacement product test system
- Decision
- granted (DENG)
- Decision date
- 2025-05-22
- Date received
- 2024-07-01
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- SES
- Device name
- Non-Factor Replacement Product Test System
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.7298
- Implant
- N
- Life sustain/support
- N