FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge IRON

Primary DI
00842768015236
Brand
Dimension Vista® Flex® reagent cartridge IRON
Company
Siemens Healthcare Diagnostics Inc.
Model
10445135
Catalog number
K3085
Device description
Iron Flex® reagent cartridge, 240 tests
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061793000DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.2006-08-07JIY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015236PrimaryGS10
00630414005058Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015236008427680152368427680152360842768015236
00630414005058006304140050586304140050580630414005058

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
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00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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
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