GenaCheck® COVID-19 Rapid Self-Test 4T

GUDID 00810143620399

Genabio Diagnostics Inc.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00810143620399
• NIH Device Record Key: a0fc5750-f0ad-45dd-998b-fade400a0a60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck® COVID-19 Rapid Self-Test 4T
• Version Model Number: N/A
• 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: 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	00810143620399 [Primary]

FDA Product Code

• QYT: Over-The-Counter Covid-19 Antigen Test

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: 2026-01-29
• Device Publish Date: 2026-01-21

Devices Manufactured by Genabio Diagnostics Inc.

• 00810143620122 - GenaCheck® COVID-19 Rapid Self-Test 2T: 2026-01-29
• 00810143620382 - GenaCheck® COVID-19 Rapid Self-Test 20T: 2026-01-29
• 00810143620399 - GenaCheck® COVID-19 Rapid Self-Test 4T: 2026-01-29
• 00810143620399 - GenaCheck® COVID-19 Rapid Self-Test 4T: 2026-01-29
• 00810143620344 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test: 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T
• 00810143620368 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test: 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T
• 00810143620214 - GenaCheck® FSH At-Home Menopause Test: 2025-03-06
• 00810143620221 - GenaCheck® Early Result Pregnancy Test: 2025-03-06
• 00810143620115 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21