The following data is part of a De Novo classification by Biofire Defense, Llc with the FDA for Filmarray Ngds Warrior Panel.
DeNovo ID | DEN160048 |
Device Name: | FilmArray NGDS Warrior Panel |
Classification | 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 Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd |
Applicant | BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 |
Contact | Cynthia Phillips |
Product Code | PRD |
CFR Regulation Number | Device Classification Under Section 513(f)(2)(de N [🔎] |
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 | Immunology |
Type | Direct |
Date Received | 2016-10-17 |
Decision Date | 2017-02-14 |
Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851458005099 | DEN160048 | 000 |