FDA.reportPublic FDA data

K-ASSAY® UIBC Calibrator

Primary DI
00816426021419
Brand
K-ASSAY® UIBC Calibrator
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-302C
Catalog number
KAI-302C
Device description
For the calibration of the K-ASSAY® UIBC assay.
Published
2019-04-09
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
JMOFerrozine (Colorimetric) Iron Binding Capacity

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426021419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426021419008164260214198164260214190816426021419

GMDN Terms#

Term, Definition table
TermDefinition
Unsaturated iron binding capacity (UIBC) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of unsaturated iron binding capacity (UIBC) of a clinical specimen.

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
206-575-8068diagnostics@k-assay.com

Regulatory Flags#

DUNS number
197934250
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
00816426020894K-ASSAY® Plasma ControlK81C-6MK81C-6M2016-09-16
00816426020924K-ASSAY® Coagulation ControlK104C-10MK104C-10M2016-09-16
00816426021013K-ASSAY® Coagulation ControlK204C-10MK204C-10M2016-09-16
00816426021099K-ASSAY® Factor XIII ControlK135C-10MK135C-10M2017-02-09
00816426021129K-ASSAY® Factor XIII ControlK204C-10MK204C-10M2017-02-09
00816426021266K-ASSAY® D-Dimer ControlK92C-2MK92C-2M2018-05-30
00816426021273K-ASSAY® D-Dimer ControlK92C-4MK92C-4M2018-05-30
00816426021600K-ASSAY® Cystatin C CalibratorKAI-200CKAI-200C2026-04-16
00816426021617K-ASSAY® Cystatin C ControlK200C-2MK200C-2M2026-04-16
00816426021594K-ASSAY® UIBC ReagentKAI-305KAI-3052026-03-13
00816426021549K-ASSAY® CRP Reagent (Ver.2)KAI-375KAI-3752026-02-27
00816426021556K-ASSAY® CRP Calibrator (Ver.2)KAI-376CKAI-376C2026-02-27
00816426020146K-ASSAY® Alpha-1 AG ReagentKAI-021KAI-0212016-09-16
00816426020375K-ASSAY® Total IgE ReagentKAI-092KAI-0922016-09-16
00816426020672K-ASSAY® Total IgE CalibratorKAI-093CKAI-093C2016-09-16
00816426021389K-ASSAY® Total IgE ControlK94C-4MK94C-4M2019-01-25
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAI-400CKAI-400C2024-04-17
00816426020641K-ASSAY® CRP (3) Calibrator FKAI-086CKAI-086C2016-09-16
00816426020269K-ASSAY® Fructosamine Reagent + Calibrator (L)KAI-050KAI-0502016-09-16
00816426021402K-ASSAY® UIBC Reagent (L)KAI-301KAI-3012019-04-09

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
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
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
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