FDA.reportPublic FDA data

Hemoglobin Test Strip

Primary DI
06935740733847
Brand
Hemoglobin Test Strip
Company
Urit Medical Electronic Co., Ltd.
Model
H12,25pieces/vial×2/box
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GGMControl, Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740733847PrimaryGS10
86935740733843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740733847069357407338476935740733847
8693574073384386935740733843

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin detection IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653742429
Device count
50
Premarket exempt
true
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
06935740725705Blood Lipid AnalyzerPFS-30,1 Set/box2026-06-03
06935740725712Blood Lipid AnalyzerPFS-30A,1 Set/box2026-06-03
06935740730655Uric Acid MeterURIT-10,1 Set/box2026-06-03
06935740730679Uric Acid MeterPA-11,1 Set/box2026-06-03
06935740730716Hemoglobin MeterPH-01,1 Set/box2026-06-03
06935740730723Hemoglobin MeterPH-01A,1 Set/box2026-06-03
06935740751773Urine StripsUrineRS-11-MA2026-06-03
06935740751780URINE REAGENT STRIPSURITEST 11G2026-06-03
06935740751797URINE REAGENT STRIPSURITEST 13G2026-06-03
06935740751803Urine StripsUrineRS-132026-06-03
06935740751810Urine StripsUrineRS-102026-06-03
06935740751827URINE REAGENT STRIPSURITEST 10G2026-06-03
06935740751834Urine StripsUrineRS-112026-06-03
06935740751841Urine AnalyzerHTI CL-50 Plus2026-06-03
06935740751858Urine AnalyzerHTI CL-5002026-06-03
06935740751865URINE ANALYZERURITEST-500B2026-06-03
06935740751872URINE ANALYZERURITEST-502026-06-03
06935740751452Aspartate Aminotransferase Test StripPS 92B,25 strips/vial ×4/box2026-06-01
06935740751469Aspartate Aminotransferase Test StripPS 92A,25 strips/vial ×4/box2026-06-01
06935740751476Aspartate Aminotransferase Test StripPS 92.25 strips/vial ×4/box2026-06-01

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
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
08718734961635CueSee® CO-OXEurotrol B.V.GGM2021-12-19