BioFire® Global Fever Panel DFA2-ASY-0004

GUDID 00851458005242

BioFire® Global Fever Panel - IVD reagent kit containing 6 tests

BIOFIRE DEFENSE, LLC

Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00851458005242
NIH Device Record Key069b320a-284f-4058-b376-b167df5f56cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFire® Global Fever Panel
Version Model NumberDFA2-ASY-0004
Catalog NumberDFA2-ASY-0004
Company DUNS556915205
Company NameBIOFIRE DEFENSE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851458005242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-26
Device Publish Date2021-07-16

Devices Manufactured by BIOFIRE DEFENSE, LLC

00851458005242 - BioFire® Global Fever Panel 2021-07-26BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
00851458005242 - BioFire® Global Fever Panel 2021-07-26 BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
00851458005259 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel 2021-07-26 BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit
00851458005068 - JBAIDS2020-02-12 JBAIDS IVD Influenza A & B Detection Kit
00851458005075 - JBAIDS2020-02-12 JBAIDS IVD Influenza A Subtyping Kit
00851458005082 - JBAIDS2020-02-12 JBAIDS IVD Influenza A/H5 Detection Kit
00851458005099 - NGDS2019-08-02 FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
00851458005136 - FilmArray® NGDS Warrior Panel2019-08-02 FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
00851458005006 - JBAIDS2018-07-06 JBAIDS Instrument

Trademark Results [BioFire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOFIRE
BIOFIRE
88852597 not registered Live/Pending
Biofire Technologies Inc.
2020-03-30
BIOFIRE
BIOFIRE
87204256 not registered Live/Pending
Biofire Technologies Inc.
2016-10-14
BIOFIRE
BIOFIRE
85981790 4534857 Live/Registered
Idaho Technology, Inc.
2012-08-09
BIOFIRE
BIOFIRE
79057952 3722496 Live/Registered
CONCEPT Gesellschaft für kreative; Produktentwicklung Gesellschaft m.b.H.
2008-07-11

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