Accutrend Glucose Test Strips 11447475160

GUDID 00365702456105

Roche Diagnostics GmbH

Glucose IVD, kit, colorimetric dipstick, rapid
Primary Device ID00365702456105
NIH Device Record Keyc102dc99-3739-4817-8d80-8d9d1b3f0e68
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccutrend Glucose Test Strips
Version Model Number11447475160
Catalog Number11447475160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702456105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

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