The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel 2 Plus (rp2plus).
| DeNovo ID | DEN170017 |
| Device Name: | FilmArray Respiratory Panel 2 Plus (RP2plus) |
| Classification | Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen J. Kanack |
| Product Code | PZF |
| CFR Regulation Number | 866.4001 [🔎] |
| 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 | Pathology |
| Type | Direct |
| Date Received | 2017-03-16 |
| Decision Date | 2017-11-24 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020307 | DEN170017 | 000 |
| 00815381020291 | DEN170017 | 000 |