FDA.reportPublic FDA data

Alinity

Primary DI
00380740136178
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
08P0130
Catalog number
08P0130
Device description
Alinity c Creatinine (Enzymatic) Reagent Kit 3600 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
JFYENZYMATIC METHOD, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740136178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740136178003807401361783807401361780380740136178

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine 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 creatinine 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
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JFY2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JFY2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2024-06-14
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414317434Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
00630414306438ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
00630414301587Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
03610230006962Yumizen C1200 Creatinine PAPHORIBA ABX SASJFY2021-06-17
00811727016072Pointe Creatinine, Enzymatic ReagentHORIBA INSTRUMENTS INCORPORATEDJFY2021-01-30
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
00811727015761Pointe Creatinine Enzymatic on BS480HORIBA INSTRUMENTS INCORPORATEDJFY2020-05-28
07613336121160Creatinine plus ver.2Roche Diagnostics GmbHJFY2020-03-05
10758750031788VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JFY2019-11-13
07070060014630Afinion ACRAbbott Diagnostics Technologies ASJFY2019-05-16
07070060014654Afinion HbA1cAbbott Diagnostics Technologies ASJFY2019-05-16
00386100001995CREA Reagent Kit MEDICA CORPORATIONJFY2019-02-14
00380740136161AlinityABBOTT LABORATORIESJFY2018-08-08
10673486000573TECO DIAGNOSTICSTECO DIAGNOSTICSJFY2018-02-12
00630414595795Atellica CH ECre_2Siemens Healthcare Diagnostics Inc.JFY2017-12-22