GenaCheck® COVID-19/Flu A&B Rapid Self-Test

GUDID 00810143620344

GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T

Genabio Diagnostics Inc.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00810143620344
• NIH Device Record Key: 749a9b06-276d-4d2c-acfd-a73257949b15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck® COVID-19/Flu A&B Rapid Self-Test
• Version Model Number: RA9-E02402
• 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: true
• 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	00810143620344 [Primary]

FDA Product Code

• SCA: Multi-Analyte Respiratory Virus Antigen Detection 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: 2025-05-27
• Device Publish Date: 2025-05-19

On-Brand Devices [GenaCheck® COVID-19/Flu A&B Rapid Self-Test]

• 00810143620368: GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T
• 00810143620344: GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T