U-Catch BPU255-A3(4)

GUDID 06972428161820

Shenzhen Bioeasy Biotechnology Co., Ltd

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 06972428161820
• NIH Device Record Key: a84e9bb1-db95-4960-9d75-bdcf93103c92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Catch
• Version Model Number: U-Catch PLUS Multi-Drug Test Cup
• Catalog Number: BPU255-A3(4)
• Company DUNS: 547954309
• Company Name: Shenzhen Bioeasy Biotechnology Co., Ltd
• Device Count: 1
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972428161820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193480

FDA Product Code

• NFT: Test, Amphetamine, 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: 2023-02-24
• Device Publish Date: 2023-02-16

On-Brand Devices [U-Catch]

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