ETERBIO Fentanyl/Norfentanyl Home Test

GUDID 06977469280431

3 tests/Kit

Eterbio, Inc.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 06977469280431
• NIH Device Record Key: 6446fee5-ce41-429a-9ad5-8ebaebf50379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETERBIO Fentanyl/Norfentanyl Home Test
• Version Model Number: ETG001003
• 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: false
• 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	06977469280431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243064

FDA Product Code

• NGL: Test, Opiates, 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: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by Eterbio, Inc.

• 06977469280431 - ETERBIO Fentanyl/Norfentanyl Home Test: 2025-12-163 tests/Kit
• 06977469280431 - ETERBIO Fentanyl/Norfentanyl Home Test: 2025-12-16 3 tests/Kit
• 06977469280080 - U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold): 2024-12-26 10 Tests/Kit
• 06977469280097 - U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold): 2024-12-26 10 Tests/Kit
• 06977469280158 - U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold): 2024-12-26 20 Tests/Kit
• 06977469280189 - U-Catch XR Multi-Drug Test Cup(Colloidal Gold): 2024-12-26 25 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC,CR,PH,SG
• 06977469280219 - S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold): 2024-12-26 5 Tests/Kit;6 Panel;AMP50,BZO50,COC50,MET25,OPI40,THC50
• 06977469280004 - U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold): 2024-12-25 5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
• 06977469280011 - U-Catch PLUS Multi-Drug Test Cup Cup(Colloidal Gold): 2024-12-25 1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC