FDA.reportPublic FDA data

ST AIA-PACK ACTH

Primary DI
14560189212517
Brand
ST AIA-PACK ACTH
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
CKGRadioimmunoassay, Acth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKGRadioimmunoassay, ActhClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189212517PrimaryGS10
04560189212510Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921251714560189212517
04560189212510045601892125104560189212510

GMDN Terms#

Term, Definition table
TermDefinition
Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) 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
615-806-4671Isabelle.Lang-Zwosta@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
5
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
00816870023847ACTH AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CKG2024-09-13
00816870024806ACTH AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
00816870024844ACTH AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
04048474036473ACTH (Adrenocorticotropic Hormone) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCKG2023-08-31
05060169696457IDS ACTH IIIMMUNODIAGNOSTIC SYSTEMS LIMITEDCKG2023-08-23
00083059070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2020-07-01
00850002253160Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CKG2019-05-20
00840239036476ACTH (Adrenocorticotropic Hormone) ELISADRG International IncCKG2019-03-20
B24221ACTHUE010Adrenocorticotropic Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CKG2017-08-03
04015630939893Elecsys ACTHRoche Diagnostics GmbHCKG2017-04-21
08305900070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2016-12-07
00817830022276ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
00817830022283ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
04560189212541AIA-PACK ACTH Sample Diluting SolutionTOSOH CORPORATIONCKG2016-09-24
00630414953502IMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414960999IMMULITE® 2000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414963532IMMULITE®/IMMULITE® 1000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
04015630921522Elecsys ACTH Test SystemRoche Diagnostics GmbHCKG2016-09-20