ACCU-CHEK INFORM II 05942861001

GUDID 10365702428109

ACCU-CHEK INFORM II US 50CT 36/CS F2

Roche Diagnostics Operations, Inc.

Glucose IVD, reagent
Primary Device ID10365702428109
NIH Device Record Key99651431-8e42-4d72-b13e-8ed2133ea48a
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHEK INFORM II
Version Model Number05942861001
Catalog Number05942861001
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 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702428102 [Primary]
GS110365702428109 [Package]
Contains: 00365702428102
Package: [36 Units]
In Commercial Distribution

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

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 Date2016-08-26

On-Brand Devices [ACCU-CHEK INFORM II]

00365702474109ACCU-CHEK LINEARITY KIT U.S.
10365702428109ACCU-CHEK INFORM II US 50CT 36/CS F2
00365702237100Accu-Chek Inform II controls US 10/CS

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