Skip to contentDe Novo DEN190031
- Device
- NP Screen
- Contact
- leo chui
- De Novo number
- DEN190031
- Product code
- OJY
- Regulation
- 866.3236
- Classification name
- device to detect or measure nucleic acid from viruses associated with head and neck cancers
- Decision
- granted (DENG)
- Decision date
- 2020-05-11
- Date received
- 2019-06-24
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- OJY
- Device name
- Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3236
- Implant
- N
- Life sustain/support
- N