LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) R10 Plus-01

GUDID 14719874743571

BONRAYBIO CO., LTD.

Spermatozoa chromatin dispersion (SCD) kit IVD

• Primary Device ID: 14719874743571
• NIH Device Record Key: 24277347-c103-4f20-abe5-5ac16fc73b84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)
• Version Model Number: R10 Plus-01 Package-10 tests-US-HT
• Catalog Number: R10 Plus-01
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	14719874743571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242388

FDA Product Code

• POV: Semen Analysis Device

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: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)]

• 14719874742802: R10 Plus Package-10 tests-US-HT
• 14719874742796: R10 Plus Package-10 tests-US-BR
• 14719874743571: R10 Plus-01 Package-10 tests-US-HT
• 14719874743564: R10 Plus-01 Package-10 tests-US-BR