Eurotrol GlucoTrol-AQ

GUDID 08718734960935

Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer. A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material: GlucoTrol-AQ Low (1): 08718734961536 GlucoTrol-AQ High (3): 08718734961543

Eurotrol B.V.

Glucose IVD, control
Primary Device ID08718734960935
NIH Device Record Key8c9ddf68-0ae4-437d-9bc5-326789db7cd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEurotrol GlucoTrol-AQ
Version Model Number180.013.002
Company DUNS412925992
Company NameEurotrol B.V.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734960935 [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 Date2020-10-16
Device Publish Date2020-10-08

Devices Manufactured by Eurotrol B.V.

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