LensHooke Sperm DNA fragmentation test kit (SCD assay)

GUDID 14719874741591

BONRAYBIO CO., LTD.

Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD

• Primary Device ID: 14719874741591
• NIH Device Record Key: 2c968595-52fc-4d6e-b179-9efb3e0b7ae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Sperm DNA fragmentation test kit (SCD assay)
• Version Model Number: R10_USBR
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14719874741591 [Primary]

FDA Product Code

• IAF: Wright'S Stain

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: 2021-11-26
• Device Publish Date: 2021-11-18

Devices Manufactured by BONRAYBIO CO., LTD.

• 04719874740702 - LensHooke Semen Quality Analyzer: 2022-09-16
• 14719874741591 - LensHooke Sperm DNA fragmentation test kit (SCD assay): 2021-11-26
• 14719874741591 - LensHooke Sperm DNA fragmentation test kit (SCD assay): 2021-11-26
• 04719874741570 - LensHooke Semen Quality Analyzer: 2021-09-03
• 44719874740717 - LensHooke semen Test Cassette: 2021-07-19
• 44719874740724 - C-KUP Liquefaction Test Cup: 2021-07-19
• 44719874740762 - LensHooke semen Test Cassette: 2021-07-19
• 44719874740779 - C-KUP Liquefaction Test Cup: 2021-07-19
• 44719874741141 - LensHooke semen Test Cassette: 2021-07-19