NGDS NGDS-ASY-0006

GUDID 00851458005099

FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.

BIOFIRE DEFENSE, LLC

Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple biothreat pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00851458005099
NIH Device Record Key8563833f-b6ca-462b-b964-293ef0e2aa07
Commercial Distribution StatusIn Commercial Distribution
Brand NameNGDS
Version Model NumberNGDS-ASY-0006
Catalog NumberNGDS-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 Perscriptionfalse
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
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
GS100851458005099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-02
Device Publish Date2017-04-21

Devices Manufactured by BIOFIRE DEFENSE, LLC

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 2021-07-26 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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.