FDA.reportPublic FDA data

DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA

Primary DI
B261CANP5400
Brand
DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA
Company
Diagnostics Biochem Canada Inc
Model
CAN-P-540
Catalog number
CAN-P-540
Device description
For the quantitative measurement of 17α-hydroxyprogesterone (17α-OHP) in human serum by an ELISA (enzyme-linked immunosorbent assay).For in vitro diagnostic use.
Published
2026-04-27
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
JLXRadioimmunoassay, 17-Hydroxyprogesterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLXRadioimmunoassay, 17-HydroxyprogesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B261CANP5400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADiagnostic Automation, Inc.JLX2026-01-27
0404847401292717 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2024-11-18
00816870021164N-17-OHP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JLX2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JLX2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 WellsMONOBIND, INC.JLX2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 WellsMONOBIND, INC.JLX2024-09-13
00816870021201N-17-OHP AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.JLX2024-09-13
04048474031409Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
04048474053333Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
00840239031402Salivary 17-OH Progesterone ELISADRG International IncJLX2023-08-26
00840239053336Progesterone (17-a-OH Progesterone)DRG International IncJLX2023-08-26
04048474014297Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-08-26
0084023901292017 OH Progesterone ELISADRG International IncJLX2023-08-23
00840239012937C-Peptide ELISADRG International IncJLX2023-08-23
00840239014290Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG International IncJLX2023-08-23
00840239046659Progesterone, 17-a-OHDRG International IncJLX2023-08-22
00817830023150MP Biomedicals LLCMp Biomedicals, LLCJLX2023-08-02
0404932503362717-OH-Progesterone ELISAIBL International GmbHJLX2022-12-28
0404901613838917-OH Progesterone ELISAEUROIMMUN Medizinische Labordiagnostika AGJLX2022-12-08
B261CANP3200DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
B261CANP4000DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
06925912718048iFlash-17α-OH-PShenzhen YHLO Biotech Co., Ltd.JLX2022-10-26
0040484741292517 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847431407Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847446654Progesterone, 17-a-OH ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847453331Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00725609000625SPOTCHECKASTORIA-PACIFIC, INC.JLX2020-12-17
B2422017OHUE01017-alpha Hydroxy Progesterone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
B2422017OHUE01SLV017-alpha Hydroxy Progesterone ELISA (Saliva)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
0540056900047617OHP RIA CTDiasource Immunoassays S.A. SAJLX2020-01-15