De Novo DEN140001
- Device
- ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
- Contact
- tanis jimenez
- De Novo number
- DEN140001
- Product code
- PHF
- Regulation
- 866.5670
- Classification name
- zinc transporter 8 auto-antibody
- Decision
- granted (DENG)
- Decision date
- 2014-08-20
- Date received
- 2014-06-16
- Classification advisory
- Immunology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PHF
- Device name
- Zinc Transporter 8 Auto-Antibody
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.5670
- Implant
- N
- Life sustain/support
- N