FDA.reportPublic FDA data

DBC Pregnenolone ELISA

Primary DI
B261CANPRE4500N0
Brand
DBC Pregnenolone ELISA
Company
Diagnostics Biochem Canada Inc
Model
CAN-PRE-4500N
Catalog number
CAN-PRE-4500N
Device description
For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).For in vitro diagnostic use.
Published
2022-11-15
Public version status
Update
Distribution status
Not 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
JNGRadioimmunoassay, Pregnenolone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNGRadioimmunoassay, PregnenoloneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B261CANPRE4500N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pregnenolone 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 pregnenolone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically 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
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
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
B261CANE4208PK0DBC Estrone ELISACAN-E-420-8PKCAN-E-420-8PK2022-11-10
B261CANE6300DBC Total Estrogens ELISACAN-E-630CAN-E-6302022-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474049121Pregnenolone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJNG2023-08-31
B652IB59107Pregnenolone ELISAIBL AmericaJNG2023-06-08
B24211PRNHUE010Pregnenolone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNG2023-05-25
04049016140849Pregnenolone ELISAEUROIMMUN Medizinische Labordiagnostika AGJNG2022-12-08
B261CANPRE45000DBC Pregnenolone ELISADiagnostics Biochem Canada IncJNG2022-11-10
00840239041708Pregnenolone Direct ELISADRG International IncJNG2021-06-07
00840239049124Pregnenolone ELISADRG International IncJNG2021-06-07
B24211PREHUE010Pregnenolone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNG2020-09-25