De Novo DEN110001
- Device
- RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- Contact
- gary lehnus
- De Novo number
- DEN110001
- Product code
- OUC
- Regulation
- 866.3395
- Classification name
- norovirus serological reagent
- Decision
- granted (DENG)
- Decision date
- 2011-02-23
- Date received
- 2011-02-16
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OUC
- Device name
- Norovirus Serological Reagent
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3395
- Implant
- N
- Life sustain/support
- N