BIOFIRE® FILMARRAY® Tropical Fever Panel

Basic Information

• Brand Name: BIOFIRE® FILMARRAY® Tropical Fever Panel
• Primary DI: 00815381021007
• Version / Model: 424803
• Company Name: BIOFIRE DIAGNOSTICS, LLC
• Labeler DUNS: 079280262
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-18
• Public Version: 1
• Public Version Date: 2025-02-26
• Public Version Status: New
• Public Device Record Key: a1248d34-618b-40e1-9ae9-4e7d6320e92b

Device Description

IVD reagent kit containing 6 tests.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	866.3966	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61053	Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with febrile infection in tropical areas, in a clinical specimen using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Dengue virus, Chikungunya virus, Salmonella spp, West Nile virus, Plasmodium spp., Rickettsia spp. and/or Leptospirosis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815381021007	GS1