The following data is part of a De Novo classification by Biofire Defense, Llc with the FDA for Filmarray Global Fever Panel.
| DeNovo ID | DEN200043 |
| Device Name: | FilmArray Global Fever Panel |
| Classification | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness |
| Applicant | BioFire Defense, LLC 79 West 4500 South suite 14 Salt Lake City, UT 84107 |
| Contact | Cynthia Phillips |
| Product Code | QMV |
| CFR Regulation Number | 866.3966 [🔎] |
| 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 | 2020-06-26 |
| Decision Date | 2020-11-20 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005242 | DEN200043 | 000 |