510(k) DEN200031
DEN200031 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "BioFire Respiratory Panel 2.1 (RP2.1)". The FDA issued a decision of De Novo Granted on March 17, 2021. The device falls under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents), a Class II device regulated under 21 CFR 866.3981. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 17, 2021
- Date Received
- May 19, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device Class
- Class II
- Regulation Number
- 866.3981
- Review Panel
- MI
- Submission Type
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.