Assure® Control Level 1 Control Solution (Low)

GUDID 00015482510046

For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.

ARKRAY USA, INC.

Glucose IVD, control
Primary Device ID00015482510046
NIH Device Record Key228289e2-0d3a-455b-a2e7-1a5facbcc4a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® Control Level 1 Control Solution (Low)
Version Model Number510004
Company DUNS008171162
Company NameARKRAY USA, 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

Phone1-800-566-8558
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482510046 [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 Date2019-04-09
Device Publish Date2019-04-01

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Trademark Results [Assure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSURE
ASSURE
98452802 not registered Live/Pending
Aqua Horizon LLC
2024-03-16
ASSURE
ASSURE
98235302 not registered Live/Pending
Caris MPI, Inc.
2023-10-23
ASSURE
ASSURE
98144267 not registered Live/Pending
Superior Plastics Extrusion Co Inc
2023-08-22
ASSURE
ASSURE
97901492 not registered Live/Pending
Resilient Floor Covering Institute, Inc.
2023-04-21
ASSURE
ASSURE
97614385 not registered Live/Pending
PerkinElmer Health Sciences, Inc.
2022-09-30
ASSURE
ASSURE
97526467 not registered Live/Pending
Qualia Labs, Inc.
2022-07-29
ASSURE
ASSURE
97448887 not registered Live/Pending
PRESTIGE MARKETING, LTD.
2022-06-08
ASSURE
ASSURE
90315893 not registered Live/Pending
LSI Wallcovering, Inc.
2020-11-12
ASSURE
ASSURE
90238064 not registered Live/Pending
Azure Biotech, Inc.
2020-10-06
ASSURE
ASSURE
90030227 not registered Live/Pending
Zep IP Holding LLC
2020-07-01
ASSURE
ASSURE
88908804 not registered Live/Pending
Syed Doha, Inc.
2020-05-10
ASSURE
ASSURE
88837750 not registered Live/Pending
West Affum Holdings Corp.
2020-03-17

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