Strongyloides IgG ELISA Test Kit

Basic Information

• Brand Name: Strongyloides IgG ELISA Test Kit
• Primary DI: B350GSD0130120
• Version / Model: GSD01-3012
• Catalog Number: GSD01-3012
• Company Name: Gold Standard Diagnostics Corporation
• Labeler DUNS: 790524891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-25
• Public Version: 1
• Public Version Date: 2022-12-05
• Public Version Status: New
• Public Device Record Key: c41cfecf-e41d-4b17-8d4a-8b052b8ab317

Device Description

Strongyloides 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
MDT	Elisa, Trichinella Spiralis	Microbiology	866.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52405	Strongyloides stercoralis 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 the parasitic nematode Strongyloides stercoralis in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B350GSD0130120	HIBCC

Storage Conditions

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