U-Catch YRLG27801025

GUDID 06972428162186

Shenzhen Bioeasy Biotechnology Co., Ltd

Cotinine IVD, kit, rapid ICT, clinical

• Primary Device ID: 06972428162186
• NIH Device Record Key: 73980a84-5953-4900-9f52-b521d1a790cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Catch
• Version Model Number: U-Catch Cotinine (COT) Test Dip Card
• Catalog Number: YRLG27801025
• Company DUNS: 547954309
• Company Name: Shenzhen Bioeasy Biotechnology 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972428162186 [Primary]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, Metabolites

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: 2023-03-17
• Device Publish Date: 2023-03-09

On-Brand Devices [U-Catch]

• 06972428161820: U-Catch PLUS Multi-Drug Test Cup
• 06972428162186: U-Catch Cotinine (COT) Test Dip Card