FDA.reportPublic FDA data

Eurotrol

Primary DI
08718734960478
Brand
Eurotrol
Company
Eurotrol B.V.
Model
195.004.010
Catalog number
195.004.010
Device description
Assayed Quality control solution
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLKControl, Hematocrit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLKControl, HematocritHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121467000EUROTROL HEMATOCRIT CONTROLEurotrol B.V.2013-05-10GLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734960478PrimaryGS10
08718734960485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734960478087187349604788718734960478
08718734960485087187349604858718734960485

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9785983779officeUSA@eurotrol.com

Regulatory Flags#

DUNS number
412925992
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718734962724CueSee® Coag1340.001.0052025-04-08
08718734962731CueSee® Coag2340.002.0052025-04-08
08718734962748CueSee® Coag3340.003.0052025-04-08
08718734962755CueSee® Coag4340.004.0052025-04-08
08718734962762CueSee® Coag5340.005.0052025-04-08
08718734963035CueSee® Hyperbaric1350.001.0052026-01-07
08718734963042CueSee® Hyperbaric1350.001.0052026-01-07
08718734960621Eurotrol AlbuTrolAlbuTrol Level 1189.001.0022020-10-08
08718734960645Eurotrol AlbuTrolAlbuTrol Level 2189.002.0022020-10-08
08718734962946CueSee® BGEM1344.001.0052025-07-25
08718734962953CueSee® BGEM2344.002.0052025-07-25
08718734962960CueSee® BGEM3344.003.0052025-07-25
08718734962991CueSee® BGEM1344.001.0052025-07-25
08718734963004CueSee® BGEM2344.002.0052025-07-25
08718734963011CueSee® BGEM3344.003.0052025-07-25
08718734963028CueSee® BGEM1 2 3 4 5345.000.0052025-07-25
08718734962779CueSee® Coag1340.001.0052025-04-08
08718734962786CueSee® Coag2340.002.0052025-04-08
08718734962793CueSee® Coag3340.003.0052025-04-08
08718734962809CueSee® Coag4340.004.0052025-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951293827ChemSTAT Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293834ChemSTAT Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293841ChemSTAT Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293858GEM ChemSTAT critPVP 1-4INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
00831829000137HemataChek, Low, Normal, High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000144HemataChek, Low & Normal ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000151HemataChek, Normal & High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000168HemataChek Low Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000182HemataChek Normal Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000205HemataChek High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00630414121789RAPIDQC® Hct Level ASiemens Healthcare Diagnostics Inc.GLK2016-09-24
00630414121796RAPIDQC® Hct Level BSiemens Healthcare Diagnostics Inc.GLK2016-09-24
08426950452058GEM critCheckINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950511526IL critPVPINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046653Hct Check - Low LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046660Hct Check - High LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446231GEM CVP (Calibration Valuation Product) 3 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446248GEM CVP (Calibration Valuation Product) 4 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573661GEM Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573678GEM Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573685GEM Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
06944413801875Blood Gas and Chemistry AnalyzerEdan Instruments, Inc.GLK2016-09-01
06944413802018 Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
06944413802025Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
08718734960423EurotrolEurotrol B.V.GLK2016-08-26
08718734960430EurotrolEurotrol B.V.GLK2016-08-26
08718734960454EurotrolEurotrol B.V.GLK2016-08-26