Primary Device ID | 00851458005129 |
NIH Device Record Key | 26c4ff13-5ff2-4780-b1d9-d9fe69529048 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FilmArray® 2.0 Instrument NGDS Configuration |
Version Model Number | NGDS-ASY-0002 |
Catalog Number | NGDS-ASY-0002U |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851458005129 [Primary] |
NSU | Instrumentation For Clinical Multiplex Test Systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-10-27 |
00851458005143 | NGDS FilmArray Configuration kit (no computer included). |
00851458005129 | Refurbished IVD Instrument NGDS Configuration. |
00851458005051 | IVD Instrument NGDS Configuration. |
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 |