FDA.reportPublic FDA data

Diatro•Dil-DIFF

Primary DI
05999883586082
Brand
Diatro•Dil-DIFF
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model
D101
Catalog number
D1012
Device description
Diatro•Dil-DIFF diluent is a buffered, stabilized and microfiltered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on Diatron hematology analyzers.
Published
2022-11-22
Public version status
Update
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
05999883586082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999883586082059998835860825999883586082

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume20Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3612794400Support@diatron.com

Regulatory Flags#

DUNS number
427395277
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
05999860094180Pictus 700 clinilcal chemistry analyzerPictus 700 clinilcal chemistry analyzer with ISEP700-32018-06-26
05999883586884Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-12018-06-26
05999883586891Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer W/out ISE P400-12018-06-26
25999860094153Trigger Solutions Pack226491-TRP2026-01-05
159998600941705x TBS Wash BufferTWB562025-12-11
059998600941735x TBS Wash BufferTWB562025-12-11
05999860094227Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with barcodP400-32018-06-26
05999860094234Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with ISE anP400-42018-06-26
05999883586686NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06
05999883586709CL ELECTRODE, ISE MODULECl- Electrode52032016-10-06
05999883586693K ELECTRODE, ISE MODULEK+ Electrode52022016-10-06
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleP780 Clinical Chemistry Analyzer with ISE moduleP780-12025-07-10
05999883586426P780 Clinical Chemistry AnalyzerP780 Clinical Chemistry AnalyzerP780-22025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Atellica DT Cuvettes (280pcs)113105122025-06-13
15999883586751Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586867Atellica DT Solution 4 (S4)Atellica DT Solution 4 (S4)113105102025-04-30
45999883586752Atellica DT Solution 2 (S2)Atellica DT Solution 2 (S2)113105082025-04-30
05999883586747Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
15999883586744Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
25999883586758Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30

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