FDA.reportPublic FDA data

IRON Gen.2

Primary DI
07613336226803
Brand
IRON Gen.2
Company
Roche Diagnostics GmbH
Model
10059605190
Catalog number
10059605190
Published
2025-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07613336226803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336226803076133362268037613336226803

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00380740136253AlinityABBOTT LABORATORIESJIY2018-11-07
00380740010911ARCHITECTABBOTT LABORATORIESJIY2018-07-31
00380740010928ARCHITECTABBOTT LABORATORIESJIY2018-07-31