FDA.reportPublic FDA data

LH ELISA

Primary DI
04048474041033
Brand
LH ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-4103
Catalog number
EIA-4103
Device description
The Quantitative Determination of Luteinizing Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.
Published
2023-08-31
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
04048474041033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474041033040484740410334048474041033

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

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
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
B261CANLH40400DBC Luteinizing Hormone (LH) ELISADiagnostics Biochem Canada IncCEP2022-11-15
06925912718925iFlash-LHShenzhen YHLO Biotech Co., Ltd.CEP2022-10-26