LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)

Basic Information

• Brand Name: LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)
• Primary DI: 14719874742802
• Version / Model: R10 Plus Package-10 tests-US-HT
• Catalog Number: R10 Plus
• Company Name: BONRAYBIO CO., LTD.
• Labeler DUNS: 658872369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-16
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: fe1448fb-047e-45fc-a407-ab6511f9f28e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
IAF	Wright'S Stain	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66248	Spermatozoa chromatin dispersion (SCD) kit IVD	A collection of reagents and other associated materials intended to be used to visualize and determine the level of DNA fragmentation in spermatozoa, to aid in the assessment of male fertility using a cell-based optical technique (e.g., microscopy, flow cytometry). It typically consists of a denaturant, lysis solution, and/or microscope slides.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14719874742802	GS1