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 Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control Multiple-type tropical pathogen nucleic acid IVD, control| Primary Device ID | 00851458005259 |
| NIH Device Record Key | 4ce4946c-7539-48a4-9f67-a962a458f317 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel |
| Version Model Number | DFA2-ASY-0006 |
| Catalog Number | DFA2-ASY-0006 |
| Company DUNS | 556915205 |
| Company Name | BIOFIRE DEFENSE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851458005259 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202382
FDA Product Code
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-26 |
| Device Publish Date | 2021-07-16 |
Devices Manufactured by BIOFIRE DEFENSE, LLC
| 00851458005297 - FILMARRAY® COMMERCIAL LAPTOP | 2024-03-27 FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument |
| 00851458005273 - BioFire® Global Fever Special Pathogens Panel | 2023-09-08 BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests |
| 00851458005280 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane | 2023-09-08 BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit |
| 00851458005228 - BioFire® COVID-19 Test 2 | 2023-02-24 BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests |
| 00851458005235 - BioFire® COVID-19 Test 2 | 2023-02-24 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 |
| 00851458005068 - JBAIDS | 2020-02-12 JBAIDS IVD Influenza A & B Detection Kit |
Trademark Results [BIOFIRE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOFIRE 97123037 not registered Live/Pending |
Biofire Technologies Inc. 2021-11-12 |
 BIOFIRE 88852597 not registered Live/Pending |
Biofire Technologies Inc. 2020-03-30 |
 BIOFIRE 87204256 not registered Live/Pending |
Biofire Technologies Inc. 2016-10-14 |
 BIOFIRE 85981790 4534857 Live/Registered |
Idaho Technology, Inc. 2012-08-09 |
 BIOFIRE 79057952 3722496 Live/Registered |
CONCEPT Gesellschaft für kreative; Produktentwicklung Gesellschaft m.b.H. 2008-07-11 |
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