FDA.reportPublic FDA data

VITROS

Primary DI
10758750009398
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
1612365
Catalog number
1612365
Device description
VITROS Chemistry Products BuBc Slides
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CIGDIAZO COLORIMETRY, BILIRUBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750009395PackageGS130In Commercial Distribution
10758750009398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000939520758750009395
1075875000939810758750009398

GMDN Terms#

Term, Definition table
TermDefinition
Total bilirubin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total bilirubin in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
07613336235508Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-02-04
07613336235515Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
07613336235522Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
00630414614755Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414614922Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00380740167561ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167585AlinityABBOTT IRELANDCIG2024-08-15
00850053916045IDG/SanzayIDG/SANZAY CorporationCIG2024-01-08
04015630924912Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
04015630927531Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
10673486001204Teco Diagnostics Direct Bilirubin TC-MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001211Teco Diagnostics Direct Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001280Teco Diagnostics Total Bilirubin TC MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001297Teco Diagnostics Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001303Teco Diagnostics Direct and Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
00852169008317ClearChem Diagnostics Inc. Total BilirubinCLEARCHEM DIAGNOSTICS INC.CIG2023-01-20
00852169008324ClearChem Diagnostics Inc. Direct BilirubinCLEARCHEM DIAGNOSTICS INC.CIG2023-01-20
00811727015952Pointe Total Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00811727016133Pointe Direct Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00811727016256Pointe Total Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00842768014192Dimension® Flex® reagent cartridge URCASiemens Healthcare Diagnostics Inc.CIG2020-09-24
03610230006870Yumizen C1200 Direct BilirubinHORIBA ABX SASCIG2020-08-28
03610230006887Yumizen C1200 Total BilirubinHORIBA ABX SASCIG2020-08-28
00811727015822Pointe Direct Bilirubin for BS480HORIBA INSTRUMENTS INCORPORATEDCIG2020-05-28
00380740174965ARCHITECTAbbott GmbHCIG2020-04-12
00380740174972ARCHITECTAbbott GmbHCIG2020-04-12
07613336164884Direct BilirubinRoche Diagnostics GmbHCIG2020-03-13