FDA.report

TOTAL-IRON BINDING CAPACITY (TIBC)

Primary DI
05055273209495
Brand
TOTAL-IRON BINDING CAPACITY (TIBC)
Company
RANDOX LABORATORIES LIMITED
Model
TI8331
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JMOFerrozine (Colorimetric) Iron Binding Capacity

Product Code Classifications

CodeDeviceSpecialtyClass
JMOFerrozine (Colorimetric) Iron Binding CapacityClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273209495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273209495050552732094955055273209495

GMDN Terms

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)].

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05055273210101Liquid Immunoassay Control – Level 1 (IA CONTROL 1)LIA5142LIA51422025-03-24
05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21

Other Devices Sharing Product Codes

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 ReagentPOINTE SCIENTIFIC, INC.JMO2021-01-30
00811727016263Pointe TIBC ReagentPOINTE SCIENTIFIC, INC.JMO2021-01-30
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
00842768015465Dimension Vista® Flex® reagent cartridge TIBCSiemens 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
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