FDA.reportPublic FDA data

VITROS

Primary DI
20758750005021
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8559825
Catalog number
8559825
Device description
VITROS Chemistry Products Specialty Diluent
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20758750005021PackageGS160In Commercial Distribution
10758750005024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000502120758750005021
1075875000502410758750005024

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
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
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

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
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