De Novo DEN150030
- Device
- KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- Contact
- brian deis
- De Novo number
- DEN150030
- Product code
- PNI
- Regulation
- 866.5665
- Classification name
- aquaporin-4 autoantibody
- Decision
- granted (DENG)
- Decision date
- 2016-04-25
- Date received
- 2015-07-02
- Classification advisory
- Immunology
- Review advisory
- Immunology
- Type
- Direct
Current FDA Classification#
- Product code
- PNI
- Device name
- Aquaporin-4 Autoantibody
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.5665
- Implant
- N
- Life sustain/support
- N