Genabio COVID-19 Rapid Self-Test Kit

GUDID 00196852953004

Genabio Diagnostics Inc.

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

• Primary Device ID: 00196852953004
• NIH Device Record Key: 363e402e-75fb-4856-bd11-12c4d3e93ace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genabio COVID-19 Rapid Self-Test Kit
• Version Model Number: RA9-E00302
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 2
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852254316 [Unit of Use]
GS1	00196852953004 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2022-08-15
• Device Publish Date: 2022-08-06

On-Brand Devices [Genabio COVID-19 Rapid Self-Test Kit]

• 00196852953004: RA9-E00302
• 00196852254316: RA9-E00305
• 00860008954862: RA9-E00302
• 00810143620184: N/A