FDA.reportPublic FDA data

Atellica CH TIBC

Primary DI
00630414595535
Brand
Atellica CH TIBC
Company
Siemens Healthcare Diagnostics Inc.
Model
11097525
Catalog number
11097525
Device description
Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T
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
K000781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000781000DIRECT TIBC KITReference Diagnostics, Inc.2000-05-02JMO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595535006304145955356304145955350630414595535

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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
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

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
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
05060500091439Synermed®INFRARED LABORATORY SYSTEMS LLCJMO2016-09-20