Gold Standard Diagnostics H. pylori ELISA IgA Test Kit

Basic Information

• Brand Name: Gold Standard Diagnostics H. pylori ELISA IgA Test Kit
• Primary DI: B350GSD0110010
• Version / Model: GSD01-1001
• Company Name: Gold Standard Diagnostics Corporation
• Labeler DUNS: 790524891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 3
• Public Version Date: 2021-06-04
• Public Version Status: Update
• Public Device Record Key: 84ba849f-595b-4c38-bc96-efb9f04fe323

Device Description

Gold Standard Diagnostics H. pylori ELISA IgA Test Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
LYR	Helicobacter Pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51004	Helicobacter pylori immunoglobulin A (IgA) 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 A (IgA) antibodies to Helicobacter pylori bacteria 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	B350GSD0110010	HIBCC

Storage Conditions

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