FDA.reportPublic FDA data

HemoTrol WB

Primary DI
08718734960980
Brand
HemoTrol WB
Company
Eurotrol B.V.
Model
Normal
Catalog number
08718734960959
Device description
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
Published
2019-03-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GGMControl, Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182744000HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.2019-02-01GGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734960959PackageGS12Not in Commercial Distribution
08718734960980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734960959087187349609598718734960959
08718734960980087187349609808718734960980

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) 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 total haemoglobin (totHb) in a clinical specimen.

Regulatory Flags#

DUNS number
412925992
Device count
1
Lot or batch
true
Manufacturing date on label
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
06935740730716Hemoglobin MeterUrit Medical Electronic Co., Ltd.GGM2026-06-03
06935740730723Hemoglobin MeterUrit Medical Electronic Co., Ltd.GGM2026-06-03
06935740751513Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
06935740751520Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
08718734962649CueSee® CO-OXEurotrol B.V.GGM2025-01-23
08718734962656CueSee® CO-OXEurotrol B.V.GGM2025-01-23
06935740726993Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-09-20
06935740733830Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733847Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733854Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2024-07-12
04048534001557DiaSpect Control Pack HBT1DiaSpect Medical GmbHGGM2022-12-20
04048534001564DiaSpect Control Pack HBT2DiaSpect Medical GmbHGGM2022-12-20
04048534001571DiaSpect Control Pack HBT3DiaSpect Medical GmbHGGM2022-12-20
04048534001588DiaSpect Control Pack HBT4DiaSpect Medical GmbHGGM2022-12-20
08718734961024CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961048CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961550CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961567CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961574CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961581CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961598CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961000CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961062CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961079CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961086CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961604CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962397CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961611CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962403CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961628CueSee® CO-OXEurotrol B.V.GGM2021-12-19