FDA.reportPublic FDA data

BioFire® Global Fever Special Pathogens Panel

Primary DI
00851458005273
Brand
BioFire® Global Fever Special Pathogens Panel
Company
BIOFIRE DEFENSE, LLC
Model
DFA2-ASY-0018
Catalog number
DFA2-ASY-0018
Device description
BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests
Published
2023-08-31
Public version status
New
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
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
QVRMultiplex Nucleic Acid Detection System For Biothreat Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2
QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile IllnessMicrobiology2
QVRMultiplex Nucleic Acid Detection System For Biothreat AgentsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213362000BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelBiofire Defense, LLC2023-03-22QVR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851458005273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851458005273008514580052738514580052730851458005273

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type biothreat/febrile infection-associated 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 (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen, using a nucleic acid technique (NAT). It is typically used to aid diagnosis incidences of suspected exposure to biological agents used in bioterrorism or biological warfare.

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
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
00851458005242BioFire® Global Fever Panel DFA2-ASY-0004DFA2-ASY-00042021-07-16
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

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Primary DI, Brand, Company table
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00851458005310BioFire Warrior Panel Control KitBIOFIRE DEFENSE, LLCPMN2025-08-10
00852720008145SPOTFIRE RSP Pos & Neg ControlsMmqciPMN2025-06-18
00815381021007BIOFIRE® FILMARRAY® Tropical Fever PanelBIOFIRE DIAGNOSTICS, LLCQMV2025-02-18
00850063063012DASH® Negative Control Swabs KitNuclein, LLCPMN2025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitNuclein, LLCPMN2025-01-06
15420045517059Aptima®Hologic, Inc.PMN2024-12-19
15420045517066Aptima®Hologic, Inc.PMN2024-12-19
30014613340485SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
30014613340492SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
M70880113943T2Biothreat® Reagent TraysT2 BIOSYSTEMS, INC.QVR2023-11-07
M70885113963T2Biothreat® QCheck Positive Kit T2 BIOSYSTEMS, INC.QVR2023-11-07
M70885113983T2Biothreat® QCheck Negative KitT2 BIOSYSTEMS, INC.QVR2023-11-07
M70890114000T2Biothreat® Cartridge KitT2 BIOSYSTEMS, INC.QVR2023-11-07
M70880113930T2Biothreat® Reagent TraysT2 BIOSYSTEMS, INC.QVR2023-11-07
M70883113950T2Biothreat® QCheck Positive Kit T2 BIOSYSTEMS, INC.QVR2023-11-07
M70883113970T2Biothreat® QCheck Negative KitT2 BIOSYSTEMS, INC.QVR2023-11-07
00852720008091SPOTFIRE RSP Positive ControlMmqciPMN2023-09-15
00852720008107SPOTFIRE RSP Negative ControlMmqciPMN2023-09-15
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCQMV2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCQVR2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCPMN2023-08-31
00844509002437MDx-Chex for BC-GNSTRECK, INC.PMN2023-08-09
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01220000260238NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
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