The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Filmarray Meningitis/encephalitis(me) Panel.
| DeNovo ID | DEN150013 |
| Device Name: | FilmArray Meningitis/Encephalitis(ME) Panel |
| Classification | Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System |
| Applicant | BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Kristen J Kanack |
| Product Code | PLO |
| CFR Regulation Number | 866.3970 [🔎] |
| 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 | 2015-04-09 |
| Decision Date | 2015-10-08 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020130 | DEN150013 | 000 |
| 00815381020123 | DEN150013 | 000 |