FDA.reportPublic FDA data

BioFire® Global Fever Panel

Primary DI
00851458005242
Brand
BioFire® Global Fever Panel
Company
BIOFIRE DEFENSE, LLC
Model
DFA2-ASY-0004
Catalog number
DFA2-ASY-0004
Device description
BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
Published
2021-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile IllnessMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200043000
K220870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200043000FilmArray Global Fever PanelBiofire Defense, LLC2020-11-20QMV
K220870000BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLC2022-10-20QMV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851458005242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851458005242008514580052428514580052420851458005242

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-262-3592support@biofiredefense.com

Regulatory Flags#

DUNS number
556915205
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851458005327SPOTFIRE Control Station - ITARFAST-ASY-0001-AFAST-ASY-0001-A2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARFAST-ASY-0001-BFAST-ASY-0001-B2025-12-16
00851458005303BioFire Warrior PanelNGDS-ASY-0018NGDS-ASY-00182025-08-10
00851458005310BioFire Warrior Panel Control KitDFA2-ASY-0047DFA2-ASY-00472025-08-10
00851458005297FILMARRAY® COMMERCIAL LAPTOPCOMP-SUB-0034COMP-SUB-00342024-03-19
00851458005051FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-00022017-10-27
00851458005112FILMARRAY1.5FLM1-ASY-01212016-09-22
00851458005129FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-0002U2017-10-27
00851458005143FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0004NGDS-ASY-00042017-12-15
00851458005266FILMARRAY NGDS WARRIOR PANEL - CADFA2-ASY-0012DFA2-ASY-00122024-06-20
00851458005273BioFire® Global Fever Special Pathogens PanelDFA2-ASY-0018DFA2-ASY-00182023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneDFA2-ASY-0019DFA2-ASY-00192023-08-31
00851458005099NGDSNGDS-ASY-0006NGDS-ASY-00062017-04-21
00851458005136FilmArray® NGDS Warrior PanelNGDS-ASY-0007NGDS-ASY-00072017-10-24
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-0006DFA2-ASY-00062021-07-16
00851458005228BioFire® COVID-19 Test 2DFA2-ASY-0015DFA2-ASY-00152023-02-16
00851458005235BioFire® COVID-19 Test 2DFA2-ASY-0016DFA2-ASY-00162023-02-16
00851458005020JBAIDSJRPD-ASY-0124JRPD-ASY-01242016-09-07
00851458005006JBAIDSJB01JRPD-ASY-00012016-09-07
00851458005013JBAIDSJRPD-ASY-0016JRPD-ASY-00162016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381021007BIOFIRE® FILMARRAY® Tropical Fever PanelBIOFIRE DIAGNOSTICS, LLCQMV2025-02-18
00851458005273BioFire® Global Fever Special Pathogens PanelBIOFIRE DEFENSE, LLCQMV2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCQMV2023-08-31