De Novo DEN200031
- Device
- BioFire Respiratory Panel 2.1 (RP2.1)
- Contact
- kristen j kanack
- De Novo number
- DEN200031
- Product code
- QOF
- Regulation
- 866.3981
- Classification name
- multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
- Decision
- granted (DENG)
- Decision date
- 2021-03-17
- Date received
- 2020-05-19
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QOF
- Device name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3981
- Implant
- N
- Life sustain/support
- N