ACCU-CHEK GUIDE

GUDID 00365702688100

ACCU-CHEK GUIDE 2-LEVEL CONTROLS US

Roche Diagnostics Operations, Inc.

Glucose IVD, control
Primary Device ID00365702688100
NIH Device Record Key81115b25-695b-4c58-bcde-17f823ec4ee1
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHEK GUIDE
Version Model Number07748906001
Company DUNS141608724
Company NameRoche Diagnostics Operations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702688100 [Primary]
GS120365702688104 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-02

On-Brand Devices [ACCU-CHEK GUIDE]

00365702729100Accu-Chek Guide Retail Kit FCN mg/dl US
10365702728100Accu-Chek Guide Sample Kit FCN mg/dl US
10365702726106Accu-Chek Guide Mail Order 50 ct
00365702719101Accu-Chek Guide 50ct HN 36/cs
00365702712102ACCU-CHEK GUIDE 100CT STRIP 24/CS
00365702710108Accu-Chek Guide 25ct Strip 36/cs
00365702702066ACCU-CHEK GUIDE METER ONLY MG/DL US
00365702702042ACCU-CHEK GUIDE RETAIL KIT MG/DL
10365702702032ACCU-CHEK GUIDE SAMPLE KIT MG/DL
00365702701977ACCU-CHEK GUIDE 10CT STRIP 36/CS
00365702701953ACCU-CHEK GUIDE 50CT STRIP 36/CS
00365702701908VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE
00365702688100ACCU-CHEK GUIDE 2-LEVEL CONTROLS US
00365702609105ACCU-CHEK GUIDE MG/DL METER 923 (US)

Trademark Results [ACCU-CHEK GUIDE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
86308216 5256607 Live/Registered
ROCHE DIABETES CARE GMBH
2014-06-12
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
85453493 not registered Dead/Abandoned
Roche Diagnostics GmbH
2011-10-21
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
77280757 not registered Dead/Abandoned
Roche Diagnostics GmbH
2007-09-17

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