U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)

GUDID 06977469280097

10 Tests/Kit

Eterbio, Inc.

Cotinine IVD, kit, rapid ICT, clinical

• Primary Device ID: 06977469280097
• NIH Device Record Key: 48f1eab1-fdad-4c8e-b81b-b8e6c6ab3b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)
• Version Model Number: ETG022010
• Company DUNS: 638595825
• Company Name: Eterbio, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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	06977469280097 [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: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)]

• 06977469280158: 20 Tests/Kit
• 06977469280097: 10 Tests/Kit