FDA.reportPublic FDA data

ST AIA-PACK DHEA-S

Primary DI
24560189212569
Brand
ST AIA-PACK DHEA-S
Company
TOSOH CORPORATION
Model
N/A
Published
2019-07-24
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
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24560189212569PackageGS110In Commercial Distribution
14560189212562PrimaryGS10
04560189212565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2456018921256924560189212569
1456018921256214560189212562
04560189212565045601892125654560189212565

GMDN Terms#

Term, Definition table
TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using a chemiluminescent immunoassay 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
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
5
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
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
07613336232132Ionify Steroids 2Roche Diagnostics GmbHJKC2025-12-11
04049325034754DHEA ELISAIBL International GmbHJKC2025-04-30
00630414652597Atellica IM DHEAS2 (REF) 500TSiemens Healthcare Diagnostics Inc.JKC2025-03-20
00630414632926Atellica IM DHEAS2 100T KITSiemens Healthcare Diagnostics Inc.JKC2025-03-20
00630414321486Atellica IM DHEAS2 (REF) 500TSiemens Healthcare Diagnostics Inc.JKC2025-03-20
04048474015621DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2024-11-22
04048474053463DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474053470DHEA-S DRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474034158DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-29
00840239053466DHEADRG International IncJKC2023-08-26
00840239053473DHEA-S DRG International IncJKC2023-08-26
04048474046526DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-26
00840239034151DHEA ELISADRG International IncJKC2023-08-24
00840239015624DHEA-S ELISADRG International IncJKC2023-08-23
00817830023020MP Biomedicals LLCMp Biomedicals, LLCJKC2023-08-01
15099590211509DHEA-S-7 RIAIMMUNOTECH s.r.o.JKC2023-07-06
04049016152170Dehydroepiandrosterone (DHEA) ELISAEUROIMMUN Medizinische Labordiagnostika AGJKC2022-12-08
04049016140368Dehydroepiandrosterone Sulfate (DHEA-S) ELISAEUROIMMUN Medizinische Labordiagnostika AGJKC2022-12-08
B261CANDH4900DBC Dehydroepiandrosterone (DHEA) ELISADiagnostics Biochem Canada IncJKC2022-11-10
B261CANDHS4800DBC Dehydroepiandrosterone Sulfate (DHEAS) ELISADiagnostics Biochem Canada IncJKC2022-11-10
06925912718550iFlash-DHEA-SShenzhen YHLO Biotech Co., Ltd.JKC2022-10-26
B24211HEAHUE010Dehydroepiandrosterone (DHEA) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
B24220DHSHUE010DHEA-S ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
15099590201432Access DHEA-SBeckman Coulter, Inc.JKC2021-09-23
15099590201449Access DHEA-S CalibratorsBeckman Coulter, Inc.JKC2021-09-23
00404847415629DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847434156DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453461DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453478DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00840239046529DHEA-S ELISADRG International IncJKC2021-06-07