FDA.reportPublic FDA data

Alinity

Primary DI
00380740136253
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
08P3920
Catalog number
08P3920
Device description
Alinity c Iron Reagent Kit 2300 Tests
Published
2018-11-07
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
JIYPhotometric method, iron (non-heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740136253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740136253003807401362533807401362530380740136253

GMDN Terms#

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

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
Premarket exempt
true
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
07613336226803IRON Gen.2Roche Diagnostics GmbHJIY2025-01-14
10673486001983Teco Diagnostics Iron/TIBC Reagent SetTECO DIAGNOSTICSJIY2023-11-13
10673486002003Teco Diagnostics Iron Reagent Kit for TC MatrixTECO DIAGNOSTICSJIY2023-11-13
00380740160692ARCHITECTABBOTT IRELANDJIY2023-10-20
00380740160708ARCHITECTABBOTT IRELANDJIY2023-10-20
00380740168285AlinityABBOTT IRELANDJIY2023-10-20
00630414610849Atellica CH Iron3 (Iron3)Siemens Healthcare Diagnostics Inc.JIY2023-05-10
00630414305011Atellica CH Iron3 (Iron3)Siemens Healthcare Diagnostics Inc.JIY2023-05-10
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
00817302024333CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT CC618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
00817302024463CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT DT618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
00817302024609CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT ST618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
04015630926947Iron Gen.2Roche Diagnostics GmbHJIY2021-06-11
00811727016188Pointe Iron ReagentHORIBA INSTRUMENTS INCORPORATEDJIY2021-01-30
04015630918904Iron Gen.2Roche Diagnostics GmbHJIY2021-01-18
04015630921119Unsaturated Iron-Binding CapacityRoche Diagnostics GmbHJIY2021-01-18
04015630925049Iron Gen.2Roche Diagnostics GmbHJIY2021-01-18
04015630928088Unsaturated Iron-Binding CapacityRoche Diagnostics GmbHJIY2021-01-18
00630414513157ADVIA® Chemistry IRON_2 ReagentsSiemens Healthcare Diagnostics Inc.JIY2020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 ReagentsSiemens Healthcare Diagnostics Inc.JIY2020-09-24
00630414596402Atellica CH Iron_2Siemens Healthcare Diagnostics Inc.JIY2020-09-24
00842768015236Dimension Vista® Flex® reagent cartridge IRONSiemens Healthcare Diagnostics Inc.JIY2020-09-24
00842768020414Dimension® Flex® reagent cartridge IRONSiemens Healthcare Diagnostics Inc.JIY2020-09-24
03610230007051Yumizen C1200 IronHORIBA ABX SASJIY2020-07-13
00811727015884Pointe Total Iron for the BS480HORIBA INSTRUMENTS INCORPORATEDJIY2020-05-28
10758750000289VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIY2020-04-18
10758750009244VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIY2020-04-18
07613336121344Iron Gen.2Roche Diagnostics GmbHJIY2020-03-05
00380740010911ARCHITECTABBOTT LABORATORIESJIY2018-07-31
00380740010928ARCHITECTABBOTT LABORATORIESJIY2018-07-31