FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-0002
GUDID 00851458005051
IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | 00851458005051 |
| NIH Device Record Key | 6c7748cb-8f27-4bfc-88b1-bf2de607d80d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FilmArray® 2.0 Instrument NGDS Configuration |
| Version Model Number | NGDS-ASY-0002 |
| Catalog Number | NGDS-ASY-0002 |
| 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 | 00851458005051 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143178
FDA Product Code
| NSU | Instrumentation For Clinical Multiplex Test Systems |
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 | 2017-10-27 |
On-Brand Devices [FilmArray® 2.0 Instrument NGDS Configuration]
| 00851458005143 | NGDS FilmArray Configuration kit (no computer included). |
| 00851458005129 | Refurbished IVD Instrument NGDS Configuration. |
| 00851458005051 | IVD Instrument NGDS Configuration. |
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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