FDA.reportPublic FDA data

CueSee® VeriSTAT QC

Primary DI
08718734961475
Brand
CueSee® VeriSTAT QC
Company
Eurotrol B.V.
Model
Level 1
Catalog number
221.001.010
Device description
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Published
2020-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131595000EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMEurotrol B.V.2013-07-26JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734961505PackageGS110In Commercial Distribution
08718734961475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734961505087187349615058718734961505
08718734961475087187349614758718734961475

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).

Regulatory Flags#

DUNS number
412925992
Device count
1
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
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08