The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Biofire Joint Infection (ji) Panel.
| DeNovo ID | DEN200066 |
| Device Name: | BioFire Joint Infection (JI) Panel |
| Classification | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kevin Bourzac |
| Product Code | QSN |
| CFR Regulation Number | 866.3988 [🔎] |
| 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 | 2020-10-27 |
| Decision Date | 2022-04-29 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020192 | DEN200066 | 000 |