Eurotrol AlbuTrol 189.001.002

GUDID 08718734960614

Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.

Eurotrol B.V.

Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control Albumin IVD, control
Primary Device ID08718734960614
NIH Device Record Keya0add909-b35f-48d7-bd13-86f63579b713
Commercial Distribution StatusIn Commercial Distribution
Brand NameEurotrol AlbuTrol
Version Model NumberAlbuTrol Level 1
Catalog Number189.001.002
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
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960614 [Package]
Contains: 08718734960621
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]
GS108718734960621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
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

On-Brand Devices [Eurotrol AlbuTrol]

08718734960638Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verificat
08718734960614Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verificat

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