INFINITY™ High Control Solution

GUDID 00885502016007

U.S. DIAGNOSTICS INC.

Glucose IVD, control
Primary Device ID00885502016007
NIH Device Record Key58134ad4-2420-47b6-b478-43503fccff97
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITY™ High Control Solution
Version Model NumberIGM-0024
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
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
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
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
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
GS100885502016007 [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.

10885502002007 - INFINITY™ Test Strips2024-11-11
00885502002031 - EasyGluco™G2 Test Strips2024-11-11
10885502002045 - Control™ Test Strips2024-11-11
00885502004004 - INFINITY™ 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
00885502016007 - INFINITY™ High Control Solution2018-10-25

Trademark Results [INFINITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFINITY
INFINITY
98761246 not registered Live/Pending
Zevex, Inc.
2024-09-20
INFINITY
INFINITY
98737979 not registered Live/Pending
Marten Group, Inc.
2024-09-06
INFINITY
INFINITY
98643936 not registered Live/Pending
Project Management Institute, Inc.
2024-07-11
INFINITY
INFINITY
98470220 not registered Live/Pending
IBF IP, LLC
2024-03-27
INFINITY
INFINITY
98466286 not registered Live/Pending
IBF IP, LLC
2024-03-25
INFINITY
INFINITY
98454204 not registered Live/Pending
Tanks By Mail Inc
2024-03-18
INFINITY
INFINITY
98433629 not registered Live/Pending
Infinity Generation Inc.
2024-03-05
INFINITY
INFINITY
98338571 not registered Live/Pending
Careismatic Brands, LLC
2024-01-02
INFINITY
INFINITY
98293120 not registered Live/Pending
PREFERRED COLLECTIONS INC.
2023-11-30
INFINITY
INFINITY
98275942 not registered Live/Pending
Capital One Financial Corporation
2023-11-17
INFINITY
INFINITY
98242984 not registered Live/Pending
IGH Holding Inc.
2023-10-27
INFINITY
INFINITY
98175956 not registered Live/Pending
CellFE, Inc.
2023-09-12

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