EasyGluco™ Normal Control Solution IGMNORM

GUDID 00885502004035

U.S. DIAGNOSTICS INC.

Glucose IVD, control
Primary Device ID00885502004035
NIH Device Record Keyd1888cf2-a112-42db-a21a-8deac41394a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyGluco™ Normal Control Solution
Version Model NumberIGM-0008
Catalog NumberIGMNORM
Company DUNS828116728
Company NameU.S. DIAGNOSTICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net

Operating and Storage Conditions

Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100885502004035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

Devices Manufactured by U.S. DIAGNOSTICS INC.

00885502004004 - INFINITY™ Normal Control Solution2018-10-25
00885502004035 - EasyGluco™ Normal Control Solution2018-10-25
00885502004035 - EasyGluco™ Normal Control Solution2018-10-25
00885502015000 - INFINITY™ Low Control Solution2018-10-25
00885502015031 - EasyGluco™ Low Control Solution2018-10-25
00885502016007 - INFINITY™ High Control Solution2018-10-25
00885502016038 - EasyGluco™ High Control Solution2018-10-25
00885502000006 - INFINITY™ Starter Kit2018-07-06
00885502000037 - EasyGluco™G2 Starter Kit2018-07-06

Trademark Results [EasyGluco]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EASYGLUCO
EASYGLUCO
78535487 3050072 Live/Registered
US DIAGNOSTICS, INC.
2004-12-20

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