FILMARRAY FLM1-ASY-0121
GUDID 00851458005112
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | 00851458005112 |
| NIH Device Record Key | 6de9136a-4f09-4996-ae1b-17dc025c4c0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FILMARRAY |
| Version Model Number | 1.5 |
| Catalog Number | FLM1-ASY-0121 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851458005112 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103175
FDA Product Code
| OCC | Respiratory Virus Panel Nucleic Acid Assay System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
Devices Manufactured by BIOFIRE DEFENSE, LLC
| 00851458005303 - BioFire Warrior Panel | 2025-08-18 NGDS IVD Reagent Biothreat Detection Kit containing 30 tests. |
| 00851458005310 - BioFire Warrior Panel Control Kit | 2025-08-18 IVD Reagent External Control Kit for the BioFire Warrior Panel |
| 00851458005266 - FILMARRAY NGDS WARRIOR PANEL - CA | 2024-06-28 FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version) |
| 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 |
Trademark Results [FILMARRAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILMARRAY 85939258 4554601 Live/Registered |
BioFire Diagnostics, Inc. 2013-05-22 |
 FILMARRAY 77083897 3761522 Live/Registered |
BIOFIRE DIAGNOSTICS, LLC 2007-01-16 |
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