FDA.reportPublic FDA data

E2 ELISA

Primary DI
05400569000063
Brand
E2 ELISA
Company
Diasource Immunoassays S.A. SA
Model
KAP0621
Device description
E2 ELISA
Published
2020-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CHPRADIOIMMUNOASSAY, ESTRADIOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHPRadioimmunoassay, EstradiolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400569000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569000063054005690000635400569000063

GMDN Terms#

Term, Definition table
TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458777323
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400569000209IGF-1 ELISAKAP15812020-09-11
05400569000414KIP1131KIP11312020-09-11
05400569000520IGF-1-RIA-CTKIP15882020-09-11
05400569000407hGH-IRMAKIP10812020-01-15
05400569000117INS ELISAKAP12512020-01-10
05400569000087IGFBP-3 ElisaKAP11712020-01-09
05400569000346ANDROSTENEDIONE-RIA-CTKIP04512020-10-05
05400569000452LHsp-IRMAKIP13112020-10-05
05400569000674Estrone-RIA-CTKIPI91002020-09-16
05400569000360E2 RIA CTKIP06292020-09-15
0540056900065011-DESOXYCORTISOL-RIA-CTKIPI200002020-09-15
05400569000049C-PEP-EASIAKPA04012020-09-14
05400569000377FSH IRMAKIP08412020-09-14
05400569000865Androstenedione-ELISAKAPD32652020-09-14
05400569000490PROG-RIA-CTKIP14582020-09-11
05400569001411Trypsin-RIAKIPCE072020-01-29
05400569000322C-PEP II-RIA-CTKIP04092020-01-15
05400569000353DHEA-S-RIA-CTKIP04812020-01-15
05400569000438INS-IRMAKIP1251/KIP12542020-01-15
0540056900047617OHP RIA CTKIP14092020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218389Elecsys Estradiol IIIRoche Diagnostics GmbHCHP2026-06-01
00850054026682AccuDiag™ Estradiol ELISA Diagnostic Automation, Inc.CHP2026-01-27
07613336232125Ionify Steroids 1Roche Diagnostics GmbHCHP2025-12-11
14560189216621CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
24560189216628CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
04048474046649Estradiol (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2024-11-21
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
00859410006245SalimetricsSALIMETRICS, LLCCHP2023-09-26
00859410006252SalimetricsSALIMETRICS, LLCCHP2023-09-26
04048474041880Salivary Estradiol ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474053494EstradiolDRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474061451Salivary Estradiol HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474043990Estradiol Sensitive ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-31
04048474026931Estradiol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-29
00840239041883Salivary Estradiol ELISA DRG International IncCHP2023-08-26
00840239053497EstradiolDRG International IncCHP2023-08-26
00840239061454Salivary Estradiol HS ELISADRG International IncCHP2023-08-26
00840239043993Estradiol Sensitive ELISADRG International IncCHP2023-08-25
00840239026934Estradiol ELISADRG International IncCHP2023-08-23
00840239046642Estradiol (serum)DRG International IncCHP2023-08-22
00817830023037MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023044MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023051MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023068MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
15099590211523Ultra-sensitive Estradiol RIAIMMUNOTECH s.r.o.CHP2023-07-06
15099590699383Access Sensitive EstradiolBeckman Coulter, Inc.CHP2023-06-26
00894175000787AccuDiag ™Diagnostic Automation, Inc.CHP2023-06-14
B24220EDLHUUE010Ultrasensitive Estradiol ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CHP2023-06-07
00850039602740PantexPantexCHP2023-03-17