BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-0006

GUDID 00851458005259

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit

BIOFIRE DEFENSE, LLC

Multiple-type tropical pathogen nucleic acid IVD, control
Primary Device ID00851458005259
NIH Device Record Key4ce4946c-7539-48a4-9f67-a962a458f317
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel
Version Model NumberDFA2-ASY-0006
Catalog NumberDFA2-ASY-0006
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
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
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
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
Phone801-262-3592
Emailsupport@biofiredefense.com
Phone801-262-3592
Emailsupport@biofiredefense.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851458005259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

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

00851458005266 - FILMARRAY NGDS WARRIOR PANEL - CA2024-06-28 FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
00851458005297 - FILMARRAY® COMMERCIAL LAPTOP2024-03-27 FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
00851458005273 - BioFire® Global Fever Special Pathogens Panel2023-09-08 BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests
00851458005280 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane2023-09-08 BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit
00851458005228 - BioFire® COVID-19 Test 22023-02-24 BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests
00851458005235 - BioFire® COVID-19 Test 22023-02-24 BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 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 2021-07-26BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit
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

Trademark Results [BIOFIRE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOFIRE
BIOFIRE
97123037 not registered Live/Pending
Biofire Technologies Inc.
2021-11-12
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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