FDA.reportPublic FDA data

Atellica HEMA Diluent

Primary DI
00630414289960
Brand
Atellica HEMA Diluent
Company
Siemens Healthcare Diagnostics Inc.
Model
11374304
Catalog number
11374304
Device description
AT HEMA Diluent
Published
2026-02-06
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
00630414289960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414289960006304142899606304142899600630414289960

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
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
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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414289953Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
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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
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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
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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
08719189137194Starrsed DiluentRR Mechatronics Manufacturing B.V.GIF2023-07-25
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10758750005024VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
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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