FDA.reportPublic FDA data

Alinity

Primary DI
00380740135577
Brand
Alinity
Company
Abbott GmbH
Model
07P9720
Catalog number
07P9720
Device description
Alinity c Direct Bilirubin Reagent Kit 1440 Tests
Published
2018-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380740135577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135577003807401355773807401355770380740135577

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) 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 conjugated (direct) bilirubin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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