GenaCheck Alcohol Rapid Self-Test Kit

GUDID 10810143620044

Genabio Diagnostics Inc.

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• Primary Device ID: 10810143620044
• NIH Device Record Key: 6fbe5835-5fea-457c-a5ef-044a7c2754cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck Alcohol Rapid Self-Test Kit
• Version Model Number: RA9-E01905
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810143620047 [Primary]
GS1	10810143620044 [Unit of Use]

FDA Product Code

• DMJ: Test Reagents For Ethyl Alcohol

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: 2023-10-16
• Device Publish Date: 2023-10-06

Devices Manufactured by Genabio Diagnostics Inc.

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• 00810143620030 - GenaCheck Rapid Self-Test Kit For Cannabis: 2023-10-16
• 10810143620044 - GenaCheck Alcohol Rapid Self-Test Kit: 2023-10-16
• 10810143620044 - GenaCheck Alcohol Rapid Self-Test Kit: 2023-10-16
• 10810143620051 - GenaCheck 5-Drug Rapid Self-Test Kit: 2023-10-16
• 10810143620068 - GenaCheck 12-Drug Rapid Self-Test Kit: 2023-10-16
• 00810143620085 - GenaCheck COVID-19 / Flu Rapid Self-Test Kit: 2023-10-16
• 00810143620092 - GenaCheck COVID-19 / Flu Rapid Self-Test Kit: 2023-10-16