LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) R11 Plus

GUDID 14719874742901

BONRAYBIO CO., LTD.

Biological stain IVD

• Primary Device ID: 14719874742901
• NIH Device Record Key: 94db9649-525d-4207-9027-752546ab6b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
• Version Model Number: R11 Plus Package-10 tests-US-BR
• Catalog Number: R11 Plus
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14719874742901 [Primary]

FDA Product Code

• KQC: Stains, Hematology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-16

On-Brand Devices [LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)]

• 14719874742918: R11 Plus Package-10 tests-US-HT
• 14719874742901: R11 Plus Package-10 tests-US-BR