FDA.reportPublic FDA data

DBC Growth Hormone (GH) ELISA

Primary DI
B261CANGH40700
Brand
DBC Growth Hormone (GH) ELISA
Company
Diagnostics Biochem Canada Inc
Model
CAN-GH-4070
Catalog number
CAN-GH-4070
Device description
For the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).For in vitro diagnostic use.
Published
2022-11-15
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
CFLRadioimmunoassay, Human Growth Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFLRadioimmunoassay, Human Growth HormoneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B261CANGH40700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Human growth hormone (HGH) 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 human growth hormone (HGH) 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
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
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADiagnostic Automation, Inc.CFL2026-01-27
B24211HGHHUE010Human Growth Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFL2025-01-20
04048474018646TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
04048474023961TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
00816870024813IGF-1 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024820IGF-1 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024882IGF-1 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
00816870024899IGF-1 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
04048474041408IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-31
04048474017878Human Growth Hormone (HGH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-26
00840239041401IGF-1 600 ELISADRG International IncCFL2023-08-25
00840239035523HGH (Human Growth Hormone) ELISADRG International IncCFL2023-08-24
00840239018649TGF-B1 ELISADRG International IncCFL2023-08-23
00840239023964TGF-B2 ELISADRG International IncCFL2023-08-23
06925912719281iFlash-hGHShenzhen YHLO Biotech Co., Ltd.CFL2022-10-26
03770024321562HGH-USCISBIO BIOASSAYSCFL2021-12-07
00404847441406IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-11
00840239017871Human Growth Hormone (HGH) ELISADRG International IncCFL2021-06-09
00404847418644TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
00404847423969TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
04015630926664Elecsys hGHRoche Diagnostics GmbHCFL2021-01-18
00630414601236IMMULITE® 2000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414601243IMMULITE®/IMMULITE® 1000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953212IMMULITE® Systems IG1 CONTROL IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953809IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953922IMMULITE® 2000 Systems IG1 IGF-I Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961538IMMULITE® 2000 Systems IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961552IMMULITE 2000 Systems Growth HormoneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964089IMMULITE/IMMULITE 1000 Systems Growth HormoneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24