Primary Device ID | 00885502004035 |
NIH Device Record Key | d1888cf2-a112-42db-a21a-8deac41394a4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EasyGluco™ Normal Control Solution |
Version Model Number | IGM-0008 |
Catalog Number | IGMNORM |
Company DUNS | 828116728 |
Company Name | U.S. DIAGNOSTICS INC. |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 866-216-5308 |
jkupar@usdiagnostics.net | |
Phone | 866-216-5308 |
jkupar@usdiagnostics.net |
Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885502004035 [Primary] |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-25 |
Device Publish Date | 2018-09-24 |
00885502004004 - INFINITY™ Normal Control Solution | 2018-10-25 |
00885502004035 - EasyGluco™ Normal Control Solution | 2018-10-25 |
00885502004035 - EasyGluco™ Normal Control Solution | 2018-10-25 |
00885502015000 - INFINITY™ Low Control Solution | 2018-10-25 |
00885502015031 - EasyGluco™ Low Control Solution | 2018-10-25 |
00885502016007 - INFINITY™ High Control Solution | 2018-10-25 |
00885502016038 - EasyGluco™ High Control Solution | 2018-10-25 |
00885502000006 - INFINITY™ Starter Kit | 2018-07-06 |
00885502000037 - EasyGluco™G2 Starter Kit | 2018-07-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EASYGLUCO 78535487 3050072 Live/Registered |
US DIAGNOSTICS, INC. 2004-12-20 |