FDA.reportPublic FDA data

DBC Estrone ELISA

Primary DI
B261CANE4208PK0
Brand
DBC Estrone ELISA
Company
Diagnostics Biochem Canada Inc
Model
CAN-E-420-8PK
Catalog number
CAN-E-420-8PK
Device description
For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).For in vitro diagnostic use.
Published
2022-11-10
Public version status
New
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
CGFRadioimmunoassay, Estrone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B261CANE4208PK0PrimaryHIBCC0

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.

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
1-519-681-8731dbc@dbc-labs.com

Regulatory Flags#

DUNS number
207718438
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B261CANP5400DBC 17α-Hydroxyprogesterone (17α-OHP) ELISACAN-P-540CAN-P-5402026-04-27
B261CANGLN3900DBC Glucagon ELISACAN-GLN-390CAN-GLN-3902024-10-10
B261CANPRE4500N0DBC Pregnenolone ELISACAN-PRE-4500NCAN-PRE-4500N2022-11-15
B261CANTE2500DBC Testosterone ELISACAN-TE-250CAN-TE-2502022-11-15
B261CANFTE2600DBC Free Testosterone ELISACAN-FTE-260CAN-FTE-2602022-11-10
B261CANFTE260LC80DBC Free Testosterone ELISACAN-FTE-260LC8CAN-FTE-260LC82022-11-10
B261CANE6304PK0DBC Total Estrogens ELISACAN-E-630-4PKCAN-E-630-4PK2023-01-06
B261CANAD2080DBC Androstenedione ELISACAN-AD-208CAN-AD-2082022-11-15
B261CANE4300DBC Estradiol ELISACAN-E-430CAN-E-4302022-11-15
B261CANE6400DBC Free Estriol ELISACAN-E-640CAN-E-6402022-11-15
B261CANFSH40600DBC Follicle Stimulating Hormone (FSH) ELISACAN-FSH-4060CAN-FSH-40602022-11-15
B261CANGH40700DBC Growth Hormone (GH) ELISACAN-GH-4070CAN-GH-40702022-11-15
B261CANLH40400DBC Luteinizing Hormone (LH) ELISACAN-LH-4040CAN-LH-40402022-11-15
B261CANP3050DBC Progesterone ELISACAN-P-305CAN-P-3052022-11-15
B261CANP3200DBC 17α-Hydroxyprogesterone (17α-OHP) ELISACAN-P-320CAN-P-3202022-11-15
B261CANP4000DBC 17α-Hydroxyprogesterone (17α-OHP) ELISACAN-P-400CAN-P-4002022-11-15
B261CANDH4900DBC Dehydroepiandrosterone (DHEA) ELISACAN-DH-490CAN-DH-4902022-11-10
B261CANDHS4800DBC Dehydroepiandrosterone Sulfate (DHEAS) ELISACAN-DHS-480CAN-DHS-4802022-11-10
B261CANE4200DBC Estrone ELISACAN-E-420CAN-E-4202022-11-10
B261CANE6300DBC Total Estrogens ELISACAN-E-630CAN-E-6302022-11-10

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
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
05400569005167Estrone ELISADiasource Immunoassays S.A. SACGF2020-01-09