100 Blood Glucose Test Strip

GUDID 00850065006192

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

LABSTYLE INNOVATION LTD

Glucose IVD, kit, enzyme spectrophotometry, rapid
Primary Device ID00850065006192
NIH Device Record Key4ac62b5a-3362-48fc-b77f-f5ceea191b49
Commercial Distribution StatusIn Commercial Distribution
Brand Name100 Blood Glucose Test Strip
Version Model Number1074-05
Company DUNS600039072
Company NameLABSTYLE INNOVATION LTD
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850065006192 [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 Date2018-04-25

On-Brand Devices [100 Blood Glucose Test Strip]

00850065006192The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitati
00850065006024The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitati

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