FDA.reportPublic FDA data

CL AIA-PACK T3 ADJUSTER SET

Primary DI
14562185395454
Brand
CL AIA-PACK T3 ADJUSTER SET
Company
TOSOH CORPORATION
Model
N/A
Published
2025-09-01
Public version status
New
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24562185395451PackageGS140In Commercial Distribution
14562185395454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2456218539545124562185395451
1456218539545414562185395454

GMDN Terms#

Term, Definition table
TermDefinition
Total triiodothyronine (TT3) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
615-806-4671Isabelle.Lang-Zwosta@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
07613336171516CalSet CalcitoninRoche Diagnostics GmbHJIT2026-06-01
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)Siemens Healthcare Diagnostics Inc.JIT2026-04-16
00630414622804Atellica IM CYFRA21-1 CalibratorSiemens Healthcare Diagnostics Inc.JIT2026-04-16
00816426021600K-ASSAY® Cystatin C CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJIT2026-04-16
08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbHJIT2025-05-27
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
00811403011797ISE Calibrator LowDiamond Diagnostics Inc.JIT2023-06-05
00811403011810ISE Calibrator HighDiamond Diagnostics Inc.JIT2023-06-05
00811403013036Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
00811403013180Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
15099590702137Access Unconjugated Estriol CalibratorsBeckman Coulter, Inc.JIT2023-01-10
07613336166345CalSet beta-Amyloid (1-42) IIRoche Diagnostics GmbHJIT2022-12-13
00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
00630414610870Atellica CH LDLC CALSiemens Healthcare Diagnostics Inc.JIT2022-07-08
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
00630414607047DV/DM COV2G/CV2G CALSiemens Healthcare Diagnostics Inc.JIT2021-01-22
14987481100999NEFA Standard SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIT2020-10-23
00630414293523Atellica IM Calibrator 30Siemens Healthcare Diagnostics Inc.JIT2020-05-31
00630414279190Atellica CH UCFP CalibratorSiemens Healthcare Diagnostics Inc.JIT2020-03-09
00380740156275ARCHITECTABBOTT LABORATORIESJIT2020-03-03