LensHooke X QC Slide (For Semen) QXC

GUDID 04719874742614

BONRAYBIO CO., LTD.

Sperm concentration indicator IVD, control

• Primary Device ID: 04719874742614
• NIH Device Record Key: 95739d05-01f0-4585-b4a2-595e205c37a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke X QC Slide (For Semen)
• Version Model Number: QXC Package-pcs-L0-US-HT
• Catalog Number: QXC
• 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	04719874742614 [Primary]

FDA Product Code

• NRF: Material, Quality Control, Semen Analysis

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: 2025-02-21
• Device Publish Date: 2025-02-13

On-Brand Devices [LensHooke X QC Slide (For Semen)]

• 04719874742669: QXC Package-3pcs-US
• 04719874742638: QXC Package-pcs-L2-US-HT
• 04719874742621: QXC Package-pcs-L1-US-HT
• 04719874742614: QXC Package-pcs-L0-US-HT