FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740160708
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
04T0230
Catalog number
04T0230
Device description
Iron2 1240 Tests
Published
2023-10-20
Public version status
New
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
00380740160708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740160708003807401607083807401607080380740160708

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

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
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
00380740136253AlinityABBOTT LABORATORIESJIY2018-11-07
00380740010911ARCHITECTABBOTT LABORATORIESJIY2018-07-31
00380740010928ARCHITECTABBOTT LABORATORIESJIY2018-07-31