FDA.reportPublic FDA data

DBC Luteinizing Hormone (LH) ELISA

Primary DI
B261CANLH40400
Brand
DBC Luteinizing Hormone (LH) ELISA
Company
Diagnostics Biochem Canada Inc
Model
CAN-LH-4040
Catalog number
CAN-LH-4040
Device description
For the quantitative measurement of Luteinizing Hormone (LH) 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
CEPRadioimmunoassay, Luteinizing Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B261CANLH40400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) 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 luteinizing hormone (LH) 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
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
06970429844124FloCo-Innovation Biotech Co., LtdCEP2026-03-31
07613336218402Elecsys LHRoche Diagnostics GmbHCEP2026-02-19
00850054026712AccuDiag™ LH ELISADiagnostic Automation, Inc.CEP2026-01-30
10850049545492QMedix™Diagnostic Automation, Inc.CEP2025-12-24
00850049545495QMedix™Diagnostic Automation, Inc.CEP2025-12-24
06923304611144Sims ovulation test kitWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2025-12-03
06970429844117co-innovationCo-Innovation Biotech Co., LtdCEP2025-10-20
14562185399711CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
24562185399718CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
04048474012897LH-Serum ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
04048474012903LH-Urine ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
15099590575243Access hLHBeckman Coulter, Inc.CEP2024-04-23
06923304611120FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
06923304611137FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
00050428296646CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
10050428296643CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
04048474053623LHDRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-09-01
04048474041033LH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-08-31
00840239053626LHDRG International IncCEP2023-08-26
00840239012890LH-Serum ELISADRG International IncCEP2023-08-22
00840239012906LH-Urine ELISADRG International IncCEP2023-08-22
06923304611113INSTANT Aid By PUR-estWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2023-08-15
15099590232276Access hLH CalibratorBeckman Coulter, Inc.CEP2023-06-26
00810038634036Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips)EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634050Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634586Easy@Home Ovulation Test Kit (20 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038633787Easy@Home Ovulation Test Kit (30 LH strips+30 Cups)EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634029Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips + 50 Cups )EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634487Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips + 40 Cups ) EASY HEALTHCARE CORPORATIONCEP2023-01-09
06925912718925iFlash-LHShenzhen YHLO Biotech Co., Ltd.CEP2022-10-26