FILMARRAY FLM1-ASY-0121
GUDID 00851458005112
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory| 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
| 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 | 2021-07-26 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 [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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