FDA.reportPublic FDA data

Alinity

Primary DI
00380740158415
Brand
Alinity
Company
Abbott GmbH
Model
04V5121
Catalog number
04V5121
Device description
Alinity c Total Bilirubin Reagent Kit 2750 Tests
Published
2019-01-02
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
MQMBILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740158415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740158415003807401584153807401584150380740158415

GMDN Terms#

Term, Definition table
TermDefinition
Total bilirubin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total bilirubin in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Special Storage Condition, Specify00Protect from light
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
00812559011136UNISTAT® Bilirubinometer Specimen CuvettesREICHERT, INC.MQM2025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen CuvettesREICHERT, INC.MQM2025-08-12
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
00380740167561ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167578ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167585AlinityABBOTT IRELANDMQM2024-08-15
00380740167585AlinityABBOTT IRELANDCIG2024-08-15
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSMQM2024-07-01
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
00884838096578BiliChekPhilips Medical Systems HsgMQM2022-10-21
30884838096579BiliChekPhilips Medical Systems HsgMQM2022-10-21
00811727015952Pointe Total Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00811727016133Pointe Direct Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30