U-Catch PLUS Multi-Drug Test Cup Cup(Colloidal Gold)

GUDID 06977469280011

1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC

Eterbio, Inc.

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

• Primary Device ID: 06977469280011
• NIH Device Record Key: fa8b772b-d7ec-4f8c-b3d7-ae3636477804
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Catch PLUS Multi-Drug Test Cup Cup(Colloidal Gold)
• Version Model Number: ETG004001
• Company DUNS: 638595825
• Company Name: Eterbio, Inc.
• 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: 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	06977469280011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182530

FDA Product Code

• NGI: Test, Morphine, 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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [U-Catch PLUS Multi-Drug Test Cup Cup(Colloidal Gold)]

• 06977469280042: 25 Tests/Kit;12 Panel;AMP;BAR;BUP;BZO;COC;MDMA;MET;MOP;MTD;OXY;PCP;THC;CR;PH;SG
• 06977469280011: 1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC