FDA.reportPublic FDA data

Swelab Lumi-D Diluent

Primary DI
07350040796429
Brand
Swelab Lumi-D Diluent
Company
Boule Medical AB
Model
Swelab Lumi-D Diluent 20L
Catalog number
1504514
Device description
The reagents are accessories intended to be used in combination with the Swelab Lumi.The diluent dilutes the blood sample to enable counting and sizing of red blood cells and platelets.
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
07350040796429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040796429073500407964297350040796429

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

Contacts#

Phone, Email table
PhoneEmail
1800-453-3328qualitygroup@boule.com

Regulatory Flags#

DUNS number
354417933
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
07350040790687Micro pipette, plastic EDTAMicro pipette, plastic EDTA 1x10010700392024-10-04
07350040790250Micro pipette, plastic EDTAMicro pipette, plastic EDTA 1x10010700392024-10-04
07350040791417Boule EasyCleanerBoule EasyCleaner, 50ml15045132024-10-04
07350040796399Medonic M51-D DiluentMedonic M51-D Diluent, 20L15045102024-10-04
07350040796405Medonic M51-L1 LyseMedonic M51-L1 Lyse, 200mL15045112024-10-04
07350040796412Medonic M51-L2 LyseMedonic M51-L2 Lyse, 500mL15045122024-10-04
07350040796436Swelab Lumi-L1 LyseSwelab Lumi-L1 Lyse 200mL15045152024-10-04
07350040796443Swelab Lumi-L2 LyseSwelab Lumi-L2 Lyse, 500mL15045162024-10-04
07350040796344Medonic M-seriesM16 US14001062016-09-17
07350040796351Medonic M-seriesM16M US140000732016-09-17
07350040796368Medonic M-seriesM16C US14000742016-09-17
07350040796375Medonic M-seriesM16S BD ABR US14000752016-09-17

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
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
04987562432387CELLPACK DFLSYSMEX CORPORATIONGIF2022-11-30