FDA.reportPublic FDA data

Starrsed Diluent

Primary DI
08719189137194
Brand
Starrsed Diluent
Company
RR Mechatronics Manufacturing B.V.
Model
QRR010931
Device description
Product for automatic dilution of blood samples in Starrsed ESR analyzers
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

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
08719189137194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189137194087191891371948719189137194

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
+1 401 431-6101salesusa@rrmechatronics.com

Regulatory Flags#

DUNS number
491828953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719189137132Starrsed Cleaning AgentQRR0109052023-07-25
08719189137217Starrsed Rinse SolutionQRR0109342023-07-25
08719189137224Starrsed X-CleanQRR0109462023-07-25
08719189137231Starrsed DisinfectantQRR0109472023-07-25
08719189137200Starrsed SalineQRR0109332023-07-24
08719189137149Starrsed ControlQRR0490012022-12-05
08719189137170Starrsed ControlQRR0490022022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414289960Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
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
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
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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
00630414246826Atellica Multi-Diluent 15Siemens Healthcare Diagnostics Inc.GIF2023-06-02
20758750005021VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
04987562020102CELLPACKSYSMEX CORPORATIONGIF2022-11-30
04987562020171CELLPACKSYSMEX CORPORATIONGIF2022-11-30
04987562406005CELLSHEATHSYSMEX CORPORATIONGIF2022-11-30
84987562408388UF II PACK-SEDSYSMEX CORPORATIONGIF2022-11-30
84987562408395UF II PACK-BACSYSMEX CORPORATIONGIF2022-11-30
04987562422906CELLPACK DCLSYSMEX CORPORATIONGIF2022-11-30
04987562422920CELLPACK DST SYSMEX CORPORATIONGIF2022-11-30
04987562422937CELLPACK DSTSYSMEX CORPORATIONGIF2022-11-30
14987562422941CELLPACK DSTSYSMEX CORPORATIONGIF2022-11-30
14987562422958CELLPACK DFLSYSMEX CORPORATIONGIF2022-11-30
14987562432384CELLPACK DFLSYSMEX CORPORATIONGIF2022-11-30
04987562433926UF-CELLSHEATHSYSMEX CORPORATIONGIF2022-11-30