FDA.reportPublic FDA data

DxH 500 Series Diluent

Primary DI
15099590671853
Brand
DxH 500 Series Diluent
Company
BECKMAN COULTER IRELAND INC.
Model
B36845
Catalog number
B36845
Device description
DxH 500 Series Diluent
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GIFDiluent, Blood Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590671853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959067185315099590671853

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count 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 determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
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
15099590695743iChemVELOCITYB793192026-04-27
15099590225889AQUIOS CL B301662016-09-23
15099590677466Navios EX10 Color 3 lasersB809102017-07-06
15099590682996Navios EX8 Color 2 lasersB809112017-07-06
15099590683009Navios EX6 Color 2 lasersB809122017-07-06
15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694975ClearLLab 10CB900032019-03-26
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414289953Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
00630414289960Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
14562185395393CL AIA-PACK SAMPLE DILUTING REAGENT ATOSOH CORPORATIONGIF2025-09-01
14562185399650CL AIA-PACK SAMPLE DILUTING REAGENT DTOSOH CORPORATIONGIF2025-09-01
14562185399681CL AIA-PACK Progesterone SAMPLE DILUTING REAGENTTOSOH CORPORATIONGIF2025-09-01
24562185395390CL AIA-PACK SAMPLE DILUTING REAGENT ATOSOH CORPORATIONGIF2025-09-01
24562185399657CL AIA-PACK SAMPLE DILUTING REAGENT DTOSOH CORPORATIONGIF2025-09-01
24562185399688CL AIA-PACK Progesterone SAMPLE DILUTING REAGENTTOSOH CORPORATIONGIF2025-09-01
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilBühlmann Laboratories AGGIF2025-03-04
06903053010702M-30D Diluent Shenzhen Mindray Bio-Medical Electronics Co., Ltd.GIF2025-01-17
06944904093178M-53D Diluent Shenzhen Mindray Bio-Medical Electronics Co., Ltd.GIF2025-01-17
07350040796399Medonic M51-D DiluentBoule Medical ABGIF2024-10-04
07350040796429Swelab Lumi-D DiluentBoule Medical ABGIF2024-10-04
008168700234960 Calibrator Matrix For Multi-LigandsMONOBIND, INC.GIF2024-09-13
008168700235020 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12MONOBIND, INC.GIF2024-09-13
008168700235190 Calibrator Matrix for Steroid (All) and Thyroid (T3, T4)MONOBIND, INC.GIF2024-09-13
00816870023526Serum Diluent Concentrate 10X (20.1ml) for High-Value x-H Pylori, x-Tg and x-TPOMONOBIND, INC.GIF2024-09-13
00816870024035Sample Diluent hCG-Free for High-Value Pregnancy SamplesMONOBIND, INC.GIF2024-09-13
00380740136024AlinityAbbott GmbHGIF2023-11-16
15099590744847DxHBeckman Coulter, Inc.GIF2023-08-10
15099590744830DxHBeckman Coulter, Inc.GIF2023-08-04
08719189137194Starrsed DiluentRR Mechatronics Manufacturing B.V.GIF2023-07-25
00630414237701Atellica Multi-Diluent 15Siemens Healthcare Diagnostics Inc.GIF2023-06-02
00630414246826Atellica Multi-Diluent 15Siemens Healthcare Diagnostics Inc.GIF2023-06-02
10758750005024VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
20758750005021VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
04987562408382UF II PACK-SEDSYSMEX CORPORATIONGIF2022-11-30
04987562408399UF II PACK-BACSYSMEX CORPORATIONGIF2022-11-30
04987562422944CELLPACK DSTSYSMEX CORPORATIONGIF2022-11-30
04987562422951CELLPACK DFLSYSMEX CORPORATIONGIF2022-11-30