FDA.reportPublic FDA data

AIA-PACK FT4 Calibrator Set

Primary DI
04560189211209
Brand
AIA-PACK FT4 Calibrator Set
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CECRadioimmunoassay, Free Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211209045601892112094560189211209

GMDN Terms#

Term, Definition table
TermDefinition
Free thyroxine (FT4) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of free thyroxine (FT4) in 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
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags#

DUNS number
690571724
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
14560189212081ST AIA-PACK 27.29N/A2026-02-02
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189213395ST AIA-PACK PROG II CALIBRATOR SETN/A2019-07-11
14560189210179ST AIA-PACK 27.29N/A2016-09-24
04560189283503G7 Beta-Thalassemia Elution Buffer KitN/A2016-09-24
14560189210339ST AIA-PACK TT3N/A2019-07-25
14560189212135ST AIA-PACK T-UN/A2019-07-25
04560189211742AIA-PACK SUBSTRATE SET IIn/a2019-09-02
04560189212220AIA-PACK C-Peptide Control SetN/A2019-09-02
04560189212749ST AIA-PACK hsE2 CALIBRATOR SETN/A2019-07-24
04560189211759AIA-PACK WASH CONCENTRATEN/A2019-09-02
04560189211766AIA-PACK DILUENT CONCENTRATEN/A2019-09-02
14560189210056AIA-PACK TSH 3rd-GenN/A2016-09-24
14560189210063ST AIA-PACK BetaHCGN/A2016-09-24
14560189210094ST AIA-PACK MyoglobinN/A2016-09-24
14560189210155ST AIA-PACK IgEIIN/A2016-09-24
14560189210230ST AIA-PACK AFPN/A2016-09-24
14560189210261ST AIA-PACK BMGN/A2016-09-24
14560189210315ST AIA-PACK FT4N/A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
00850049545990QMedix™Diagnostic Automation, Inc.CEC2024-02-02
04048474042665Free Thyroxine (fT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEC2023-08-31
00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
07613336175071Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-03
07613336172780Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-02
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
00630414293851Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414294292Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414599144Atellica IM FT4 MCMSiemens Healthcare Diagnostics Inc.CEC2020-09-24
00630414293684Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00630414294193Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00840239042668Free Thyroxine (fT4) ELISADRG International IncCEC2019-06-10
00816870021713Free T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870021720Free T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870021737Monobind AccuBind Free T4 ELISA Kit - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870021744Free T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CEC2019-02-11
00816870023151Free T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870023168Free T4 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870023175Free T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870023182Monobind AccuLite Free T4 CLIA Kit - 960 WellsMONOBIND, INC.CEC2019-02-11
00380740121822AlinityABBOTT IRELANDCEC2018-07-31
00380740121815AlinityABBOTT IRELANDCEC2018-05-31
00380740119799ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119805ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119812ARCHITECTABBOTT IRELANDCEC2018-05-14
08809317540382FREND Free T4NanoEnTek, Inc.CEC2018-05-04
00630414599120Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599137Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06