FDA.reportPublic FDA data

ST AIA-PACK TSH

Primary DI
14560189210360
Brand
ST AIA-PACK TSH
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
JLWRadioimmunoassay, Thyroid-Stimulating Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189210360PrimaryGS10
04560189210363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921036014560189210360
04560189210363045601892103634560189210363

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
5
Premarket exempt
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
00850049545044AccuDiag™Diagnostic Automation, Inc.JLW2024-11-14
00630414624488ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624501ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624518Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624525Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624532Atellica IM TSH3ULII MCM setSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624693Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624709ADVIA Centaur TSH3ULII MCM SETSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00850054026262AccuDiag ™Diagnostic Automation, Inc.JLW2024-03-27
00850054026538QMedix™Diagnostic Automation, Inc.JLW2024-03-06
00850054026439QMedix™Diagnostic Automation, Inc.JLW2024-01-31
04048474052664Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474052831Thyrotropin (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474041118Thyrotropin (TSH) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-31
04048474017823Thyroid Stimulating Hormone (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
04048474017908TSH (ultrasensitive) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
00840239052834Thyrotropin (TSH) ELISADRG International IncJLW2023-08-25
15099590744373Access TSH (3rd IS)Beckman Coulter, Inc.JLW2022-12-31
07613336193693Elecsys TSHRoche Diagnostics GmbHJLW2022-11-18
06947145500016MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
06947145500023MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
00725609000618SPOTCHECKASTORIA-PACIFIC, INC.JLW2020-12-17
00630414293875Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-12-12
00842768032417Dimension® EXL™/ Dimension Vista® MULTI 2 SDILSiemens Healthcare Diagnostics Inc.JLW2020-09-24
00630414293806Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-05-31
00722066001950Rapid ResponseBTNX IncJLW2019-10-16
00850392007015BioCheck TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00850392007039BioCheck U-TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00840239014832Neonatal TSH ELISADRG International IncJLW2019-06-10
00840239041111Thyrotropin (TSH) ELISADRG International IncJLW2019-06-10