FDA.reportPublic FDA data

CueSee® Coag

Primary DI
08718734962731
Brand
CueSee® Coag
Company
Eurotrol B.V.
Model
2
Catalog number
340.002.005
Device description
CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.
Published
2025-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GGNPlasma, Coagulation Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734962786PackageGS15In Commercial Distribution
08718734962731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734962786087187349627868718734962786
08718734962731087187349627318718734962731

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Regulatory Flags#

DUNS number
412925992
Device count
1
Premarket exempt
true
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
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
08718734962816CueSee® Coag5340.005.0052025-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19
00842768018909Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19