BGM GALECTIN-3

Basic Information

• Brand Name: BGM GALECTIN-3
• Primary DI: 00867444000207
• Version / Model: 001
• Company Name: CORGENIX MEDICAL CORPORATION
• Labeler DUNS: 619834542
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-26
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: f2b74c1d-6722-4ed3-bbff-3468bcaaff30

Device Description

Galectin-3 In Vitro Diagnostic Assay

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
OSX	Galectin-3 In Vitro Diagnostic Assay	Clinical Chemistry	862.1117	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48149	Galectin-3 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 galectin-3 protein in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to identify early myocardial fibrosis and heart failure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867444000207	GS1

Premarket Submissions

Submission Number	Supplement Number
K093758	000

Storage Conditions

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