The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Biofire Respiratory Panel 2.1 (rp2.1).
| DeNovo ID | DEN200031 |
| Device Name: | BioFire Respiratory Panel 2.1 (RP2.1) |
| Classification | Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents |
| Applicant | Biofire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen J Kanack |
| Product Code | QOF |
| CFR Regulation Number | 866.3981 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2020-05-19 |
| Decision Date | 2021-03-17 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020529 | DEN200031 | 000 |