De Novo DEN200066
- Device
- BioFire Joint Infection (JI) Panel
- Contact
- kevin bourzac
- De Novo number
- DEN200066
- Product code
- QSN
- Regulation
- 866.3988
- Classification name
- orthopedic infection microbial multiplex nucleic acid detection system
- Decision
- granted (DENG)
- Decision date
- 2022-04-29
- Date received
- 2020-10-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QSN
- Device name
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3988
- Implant
- N
- Life sustain/support
- N