FDA.reportPublic FDA data

Estrone ELISA

Primary DI
05400569005167
Brand
Estrone ELISA
Company
Diasource Immunoassays S.A. SA
Model
KAPDB420
Device description
Estrone ELISA
Published
2020-01-09
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
CGFRADIOIMMUNOASSAY, ESTRONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400569005167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569005167054005690051675400569005167

GMDN Terms#

Term, Definition table
TermDefinition
Estrone (oestrone) 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 estrone (oestrone) 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
04048474040791Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474041743Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474046540Estrone SerumDRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-26
00840239041746Estrone ELISADRG International IncCGF2023-08-25
15099590211547Estrone-sulfate RIAIMMUNOTECH s.r.o.CGF2023-07-06
15099590211615Estrone RIAIMMUNOTECH s.r.o.CGF2023-07-06
B652IB59105Estrone ELISAIBL AmericaCGF2023-06-08
04049016148388Estrone ELISAEUROIMMUN Medizinische Labordiagnostika AGCGF2022-12-08
B261CANE4200DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
B261CANE4208PK0DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
00404847441741Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2021-06-07
00840239040794Estrone ELISADRG International IncCGF2021-06-07
00840239046543Estrone Serum ELISADRG International IncCGF2021-06-07
B24211ESRHUE010Estrone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGF2020-09-25
05400569000674Estrone-RIA-CTDiasource Immunoassays S.A. SACGF2020-09-16