GenaCheck™ Fentanyl Urine Home-Use Test Cassette

GUDID 00860008954800

Genabio Diagnostics Inc.

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• Primary Device ID: 00860008954800
• NIH Device Record Key: b7904151-c7f5-43b8-b4af-484b8a7d81f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck™ Fentanyl Urine Home-Use Test Cassette
• Version Model Number: RA9-E02525
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com
• Phone: 1-800-614-3365
• Email: info@genabio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008954800 [Primary]
GS1	10860008954807 [Package]; Package: Carton [108 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233417

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: 2024-06-24
• Device Publish Date: 2024-06-14

Devices Manufactured by Genabio Diagnostics Inc.

• 00860008954800 - GenaCheck™ Fentanyl Urine Home-Use Test Cassette: 2024-06-24
• 00860008954800 - GenaCheck™ Fentanyl Urine Home-Use Test Cassette: 2024-06-24
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• 00810143620085 - GenaCheck COVID-19 / Flu Rapid Self-Test Kit: 2023-10-16