LensHooke Sperm DNA fragmentation test kit (SCD assay)

GUDID 14719874741591

BONRAYBIO CO., LTD.

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