De Novo DEN190056
- Device
- ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- Contact
- matthew gee
- De Novo number
- DEN190056
- Product code
- QQB
- Regulation
- 862.1622
- Classification name
- prognostic test for assessment of liver related disease progression
- Decision
- granted (DENG)
- Decision date
- 2021-08-20
- Date received
- 2019-12-26
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QQB
- Device name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1622
- Implant
- N
- Life sustain/support
- N