FDA.reportPublic FDA data

AIA-PACK T4 CALIBRATOR SET

Primary DI
04560189211803
Brand
AIA-PACK T4 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
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLIEnzyme Immunoassay, Non-Radiolabeled, Total ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211803045601892118034560189211803

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) 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 thyroxine (TT4) 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189283923Hemoglobin A1c Control SetN/A2026-01-05
04562185400571HbA1c Diluting SolutionN/A2026-01-05
04562185403060HbA1c Calibrator Set (S)N/A2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01HLC-723GR012026-01-05
0456218540493790 Sample Loader GR-90SL2026-01-05
04562185404944290 Sample LoaderGR-290SL2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnN/A2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1N/A2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2N/A2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3N/A2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LAHLC-723GR01LA2026-01-05
24560189216321CL AIA-PACK Prolactin II TEST CUPN/A2025-09-01
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETN/A2025-09-01
24560189216628CL AIA-PACK hs-E2 TEST CUPN/A2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETN/A2025-09-01
24562185395390CL AIA-PACK SAMPLE DILUTING REAGENT AN/A2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPN/A2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETN/A2025-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590754488Access Total T4 IIBeckman Coulter, Inc.KLI2025-09-19
00816870023489T4 High Sensitivity AccuBind ELISA Test System - 96 wellsMONOBIND, INC.KLI2024-09-13
00816870024851T4 High Sensitivity AccuBind ELISA Test System - 192 wellsMONOBIND, INC.KLI2024-09-13
00850049545983QMedix™Diagnostic Automation, Inc.KLI2024-02-02
04048474052794Total Thyroxine (tT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-09-01
04048474041095Free Thyroxine (fT4) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-31
04048474017816Total Thyroxine (T4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-26
00840239052797Total Thyroxine (tT4) ELISADRG International IncKLI2023-08-25
00894175000893AccuDiag ™Diagnostic Automation, Inc.KLI2023-06-14
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.KLI2022-10-26
00725609000649SPOTCHECKASTORIA-PACIFIC, INC.KLI2020-12-17
00850392007077BioCheck T4 EIA Test KitBIOCHECK, INC.KLI2019-10-08
00840239041098Free Thyroxine (fT4) ELISADRG International IncKLI2019-06-10
00840239017819Total Thyroxine (T4) ELISADRG International IncKLI2019-03-20
00380740131524AlinityABBOTT IRELANDKLI2018-12-04
00380740131517AlinityABBOTT IRELANDKLI2018-07-31
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.KLI2017-08-03
00884883005655CEDIA T4 AssayMicrogenics CorporationKLI2016-09-26
14560189210803ST AIA-PACK T4TOSOH CORPORATIONKLI2016-09-24
04560189211797AIA-PACK T4 SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONKLI2016-09-24
00842768015434Dimension Vista® Flex® reagent cartridge T4Siemens Healthcare Diagnostics Inc.KLI2016-09-24
00857969006273ACEALFA WASSERMANN, INC.KLI2016-09-24
00630414954370IMMULITE®/IMMULITE® 1000 Systems T4 Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966038IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966229IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414972992IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00884883004177DRI Thyroxine (T4)Microgenics CorporationKLI2016-09-22
04015630916016Total T4 Thyroxine)Roche Diagnostics GmbHKLI2016-09-20
00884883003446DRI Thyroxine (T4)Microgenics CorporationKLI2016-09-12