The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Biofire Global Fever Panel, Biofire Shield Control Kit For The Biofire Global Fever Panel.
| Device ID | K220870 |
| 510k Number | K220870 |
| Device Name: | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit For The BioFire Global Fever Panel |
| Classification | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness |
| Applicant | BioFire Defense, LLC 79 W 4500 S, Suite 14 Salt Lake City, UT 84107 |
| Contact | Cynthia Pillips |
| Correspondent | David Rabiger BioFire Defense, LLC 79 W 4500 S, Suite 14 Salt Lake City, UT 84107 |
| Product Code | QMV |
| CFR Regulation Number | 866.3966 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-10-20 |