GenaCheck®Fentanyl Urine Test Cassette RA9-E02525

GUDID 00860008954817

Genabio Diagnostics Inc.

Multiple drugs of abuse IVD, control

• Primary Device ID: 00860008954817
• NIH Device Record Key: df6a0e32-b857-4756-99e4-396a9bbffe28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck®Fentanyl Urine Test Cassette
• Version Model Number: N/A
• Catalog Number: RA9-E02525
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 25
• 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	00860008954817 [Primary]
GS1	86000895481700 [Unit of Use]

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: 2025-01-21
• Device Publish Date: 2025-01-13

Devices Manufactured by Genabio Diagnostics Inc.

• 00810143620115 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620139 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620146 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620153 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620184 - Genabio COVID-19 Rapid Self-Test Kit: 2025-01-21
• 00810143620191 - GenaCheck®LH At-Home Ovulation Prediction Test: 2025-01-21
• 00810143620207 - GenaCheck®PdG At-Home Ovulation Confirmation Test: 2025-01-21
• 00860008954817 - GenaCheck®Fentanyl Urine Test Cassette: 2025-01-21
• 00860008954817 - GenaCheck®Fentanyl Urine Test Cassette: 2025-01-21