FDA.reportPublic FDA data

IMMULITE® 2000 Systems MD2 Multi-Diluent 2 Sample Diluent

Primary DI
00630414982298
Brand
IMMULITE® 2000 Systems MD2 Multi-Diluent 2 Sample Diluent
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10708431
Catalog number
L2M2Z(D)
Device description
MULTI DILUENT 2 - IMMULITE - CONS - 1x25mL
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00630414982298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414982298006304149822986304149822980630414982298

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
296822794
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04
00630414245379ADVIA Centaur aTgII Quality Control (aTgII QC)11202552112025522026-02-04
00630414245386ADVIA Centaur aTgII Master Curve Material (aTgII MCM)11200352112003522026-02-04
00630414608754Atellica IM aTPOII11206076112060762026-01-26
00630414608761Atellica IM aTPOII11206077112060772026-01-26
00630414608891Atellica IM aTPOII QC11206984112069842026-01-26
00630414609492Atellica IM aTPOII Diluent11207637112076372026-01-26
00630414608570ADVIA Centaur aTPOII11206075112060752025-11-21
00630414608587ADVIA Centaur aTPOII QC11206985112069852025-11-21
00630414608747ADVIA Centaur aTPOII11206074112060742025-11-21
00630414609409ADVIA Centaur aTPOII Diluent11207635112076352025-11-21
00630414238401Atellica IM Thyroglobulin (Tg)11200449112004492025-09-22
00630414238418Atellica IM Tg11200450112004502025-09-22
00630414238425Atellica IM Tg11200534112005342025-09-22
00630414637877Atellica IM HBcT211643118116431182024-04-26

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
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
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
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