FDA.reportPublic FDA data

DHEA-S ELISA

Primary DI
04049325001787
Brand
DHEA-S ELISA
Company
IBL International GmbH
Model
RE52181
Catalog number
RE52181
Device description
DHEA-S ELISA - 96 Determinations
Published
2020-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04049325001787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049325001787040493250017874049325001787

GMDN Terms#

Term, Definition table
TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) 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 dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of adrenal hyperplasia and hirsutism.

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
+49405328910IBL@Tecan.com

Regulatory Flags#

DUNS number
312694785
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
04049325034754DHEA ELISA30252873302528732025-04-30
0404932501235617beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412020-12-29
0404932501236317beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492020-12-29
04049325008304Active-B12 (Holotranscobalamin) ELISAAX53101AX531012016-09-24
0404932503362717-OH-Progesterone ELISA30223011302230112022-12-28
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492023-09-29
0404932503055817beta-Estradiol Saliva ELISA30121045301210452023-03-09
04049325014879Unassayed Testosterone QC Material30108902301089022020-12-29
0404932501721417beta-Estradiol Saliva ELISA30121045301210452020-12-29
04049325003545Testosterone Luminescence ImmunoassayRE62031RE620312020-10-20
04049325006546Testosterone Luminescence ImmunoassayRE62039.RE62039.2020-10-20
04049325003606SaliCapsRE69991.RE69991.2020-12-29
04049325003613SaliCapsRE69995.RE69995.2020-12-29
04049325003521Progesterone Luminescence ImmunoassayRE62021RE620212020-12-29
04049325003538Progesterone Luminescence ImmunoassayRE62029RE620292020-12-29
04049325001404Acetylcholine Receptor Autoantibodies (ARAb) RRARE21021RE210212016-09-24
04049325001428Acetylcholine Receptor Autoantibodies (ARAb) RRARE21023RE210232016-09-24
04049325007727Cortisol Saliva Luminescence ImmunoassayRE62111RE621112016-09-24
04049325007734Cortisol Saliva Luminescence ImmunoassayRE62119RE621192016-09-24

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