De Novo DEN220027
- Device
- B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- Contact
- anja jagalla
- De Novo number
- DEN220027
- Product code
- QWH
- Regulation
- 862.1602
- Classification name
- prognostic test for development or progression of preeclampsia
- Decision
- granted (DENG)
- Decision date
- 2023-05-18
- Date received
- 2022-05-02
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QWH
- Device name
- Prognostic Test For Development Or Progression Of Preeclampsia
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1602
- Implant
- N
- Life sustain/support
- N