FDA.reportPublic FDA data

ST AIA-PACK ACTH Calibrator Set

Primary DI
04560189212534
Brand
ST AIA-PACK ACTH 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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189212534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189212534045601892125344560189212534

GMDN Terms#

Term, Definition table
TermDefinition
Adrenocorticotropic hormone (ACTH) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) 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
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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
14562185395454CL AIA-PACK T3 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
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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
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