FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091460
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
IR152-L
Catalog number
IR152-L
Device description
UIBC Chromogen Reagent 6 X 250 mL
Published
2016-09-20
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922784000SYNERMED UIBC REAGENT KITSynermed, Inc.1992-07-21JMO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091460050605000914605060500091460

GMDN Terms#

Term, Definition table
TermDefinition
Unsaturated iron binding capacity (UIBC) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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 Temperature0 Degrees Celsius4 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317 896-1565info@irlabsystems.com

Regulatory Flags#

DUNS number
014210494
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060500090029Synermed®IR010-RIR010-R2016-09-20
05060500090036Synermed®IR010-XIR010-X2016-09-20
05060500090043Synermed®IR010-WKIR010-WK2016-09-20
05060500090050Synermed®IR010-911IR010-9112016-09-20
05060500090067Synermed®IR010-LIR010-L2016-09-20
05060500091682Synermed®IR010-1200IR010-12002017-02-28
05060500090739Synermed®VI560-RVI560-R2016-09-20
05060500090746Synermed®VI5600-XVI5600-X2016-09-20
05060500090753Synermed®VI560-WKVI560-WK2016-09-20
05060500090760Synermed®VI560-911VI560-9112016-09-20
05060500090777Synermed®VI561-LVI561-L2016-09-20
05060500090784Synermed®VI562-LVI562-L2016-09-20
05060500091873Synermed®VI560-1200VI560-12002017-02-28
05060500090005Synermed®IR-500IR-5002016-09-20
05060500090012Synermed®IR-1200IR-12002016-12-12
05060500091538Synermed®IR954IR9542016-09-20
05060500091545Synermed®IR961-XIR961-X2016-09-20
05060500091552Synermed®IR962-XIR962-X2016-09-20
05060500091590Synermed®ISE530-KISE530-K2016-09-20
05060500091613Synermed®0010012016-09-20

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
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