Entamoeba histolytica IgG ELISA Test Kit

Basic Information

• Brand Name: Entamoeba histolytica IgG ELISA Test Kit
• Primary DI: B350GSD0130130
• Version / Model: GSD01-3013
• Catalog Number: GSD01-3013
• Company Name: Gold Standard Diagnostics Corporation
• Labeler DUNS: 790524891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: 0424a63a-eca7-400c-a907-cfd423890881

Device Description

Entamoeba histolytica IgG ELISA Test Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	866.3220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52225	Entamoeba histolytica immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B350GSD0130130	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius