FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge TIBC

Primary DI
00842768015465
Brand
Dimension Vista® Flex® reagent cartridge TIBC
Company
Siemens Healthcare Diagnostics Inc.
Model
10445134
Catalog number
K3084
Device description
Total Iron Binding Capacity Flex® reagent cartridge, 160 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
JMOFerrozine (colorimetric) iron binding capacity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMOFerrozine (Colorimetric) Iron Binding CapacityClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061020000DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.2006-05-10CKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015465PrimaryGS10
00630414005041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015465008427680154658427680154650842768015465
00630414005041006304140050416304140050410630414005041

GMDN Terms#

Term, Definition table
TermDefinition
Total iron binding capacity (TIBC) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen, using a spectrophotometry method. TIBC is determined by adding the values obtained for the concentration of serum iron and the available iron-binding capacity of transferrin [i.e., the unsaturated iron binding capacity (UIBC)].

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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00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816426021594K-ASSAY® UIBC ReagentKAMIYA BIOMEDICAL COMPANY, LLCJMO2026-03-13
10673486001983Teco Diagnostics Iron/TIBC Reagent SetTECO DIAGNOSTICSJMO2023-11-13
06971674869603BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMO2023-07-24
06971674869610BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMO2023-07-24
06971674869627BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMO2023-07-24
05055273209488TOTAL IRON-BINDING CAPACITY 2 (TIBC_2)RANDOX LABORATORIES LIMITEDJMO2022-09-23
05055273214727TOTAL IRON-BINDING CAPACITY 2 (TIBC_2)RANDOX LABORATORIES LIMITEDJMO2022-09-23
05055273214734TOTAL IRON-BINDING CAPACITY 2 (TIBC_2)RANDOX LABORATORIES LIMITEDJMO2022-09-23
00811727015969Pointe Direct TIBC ReagentHORIBA INSTRUMENTS INCORPORATEDJMO2021-01-30
00811727016263Pointe TIBC ReagentHORIBA INSTRUMENTS INCORPORATEDJMO2021-01-30
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity ReagentsSiemens Healthcare Diagnostics Inc.JMO2020-09-24
00630414595535Atellica CH TIBCSiemens Healthcare Diagnostics Inc.JMO2020-09-24
00842768005756Dimension® Flex® reagent cartridge IBCTSiemens Healthcare Diagnostics Inc.JMO2020-09-24
10758750001873VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JMO2020-04-18
07613336121597Unsaturated Iron-Binding CapacityRoche Diagnostics GmbHJMO2020-03-05
05055273206517TOTAL-IRON BINDING CAPACITY (TIBC)RANDOX LABORATORIES LIMITEDJMO2019-06-03
05055273209426IRON (Fe)RANDOX LABORATORIES LIMITEDJMO2019-06-03
05055273209433IRON (Fe)RANDOX LABORATORIES LIMITEDJMO2019-06-03
05055273209495TOTAL-IRON BINDING CAPACITY (TIBC)RANDOX LABORATORIES LIMITEDJMO2019-06-03
00816426021396K-ASSAY® UIBC ReagentKAMIYA BIOMEDICAL COMPANY, LLCJMO2019-04-09
00816426021402K-ASSAY® UIBC Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCJMO2019-04-09
00816426021419K-ASSAY® UIBC CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJMO2019-04-09
00386100002190Iron (Fe) Reagent KitMEDICA CORPORATIONJMO2019-02-14
00852169008232ClearChem Diagnostics Inc. TIBC-DirectCLEARCHEM DIAGNOSTICS INC.JMO2018-05-22
00857969006020ACEALFA WASSERMANN, INC.JMO2017-10-10
05060500091965Synermed®INFRARED LABORATORY SYSTEMS LLCJMO2017-02-28
00817302022704CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660CAROLINA LIQUID CHEMISTRIES CORPORATIONJMO2016-12-12
00817439021267Direct TIBC ReagentMedtest Dx, Inc.JMO2016-09-27
15099590011925AUBeckman Coulter, Inc.JMO2016-09-24
05060500091439Synermed®INFRARED LABORATORY SYSTEMS LLCJMO2016-09-20