De Novo DEN190025
- Device
- OraQuick Ebola Rapid Antigen Test
- Contact
- tiffany miller
- De Novo number
- DEN190025
- Product code
- QID
- Regulation
- 866.4002
- Classification name
- device to detect antigens of biothreat microbial agents in human clinical specimens
- Decision
- granted (DENG)
- Decision date
- 2019-10-10
- Date received
- 2019-05-13
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QID
- Device name
- Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.4002
- Implant
- N
- Life sustain/support
- Y