Primary Device ID | 00815381020048 |
NIH Device Record Key | a87a374f-cf95-4996-9951-b5bd58dc277e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FilmArray® 2.0 Instrument |
Version Model Number | FLM2-ASY-0001 |
Catalog Number | FLM2-ASY-0001R |
Company DUNS | 079280262 |
Company Name | BIOFIRE DIAGNOSTICS, 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 | false |
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 | 00815381020048 [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 | 2016-09-23 |
00815381020048 | Refurbished IVD Instrument (FilmArray® 2.0 Instrument). |
00815381020031 | IVD Instrument (FilmArray® 2.0 Instrument). |
00815381029058 | Refurbished IVD Instrument (FilmArray® 2.0 Instrument). |
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 |