kozekoze

GUDID 30860010252360

kozekoze Early Detection Pregnancy Test, strip, 10T/box

Guangzhou Decheng Biotechnology Co., LTD

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 30860010252360
• NIH Device Record Key: 75e1a63a-2fad-46c3-aab1-1fc67dec8156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: kozekoze
• Version Model Number: 10T
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010252369 [Primary]
GS1	30860010252360 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240643

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2025-09-08
• Device Publish Date: 2025-08-29

On-Brand Devices [kozekoze]

• 30860010252377: kozekoze Pregnancy Test, strip, 10T/Box
• 30860010252360: kozekoze Early Detection Pregnancy Test, strip, 10T/box
• 30860010252353: kozekoze Ovulation Test, strip, 10T/Box