HBA®

Basic Information

• Brand Name: HBA®
• Primary DI: 20888937025846
• Version / Model: BCT-HBA-10-US
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-10-20
• Public Version: 1
• Public Version Date: 2025-10-28
• Public Version Status: New
• Public Device Record Key: ec4128a4-801a-4f6d-8038-837b9be76df0

Device Description

HBA® Sperm-Hyaluronan Binding 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
POV	Semen Analysis Device	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58104	Sperm hyaluronic acid (HA) binding IVD, kit, binding assay	A collection of reagents and other associated materials intended to be used for the qualitative determination of the hyaluronic acid (HA) binding capacity of sperm in a clinical specimen, using a binding assay. This assay is also referred to as a sperm-hyaluronan binding assay and may be used as an indicator of sperm maturity during fertility assessment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10888937025849	GS1
Primary	20888937025846	GS1