CVS Health At Home COVID-19 Test Kit 289586

GUDID 00050428101735

CVS Health At Home COVID-19 Test Kit

DIAGNOSTIC HYBRIDS, INC.

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

• Primary Device ID: 00050428101735
• NIH Device Record Key: 7c996c6f-d721-43d8-9f35-19c7725e43ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVS Health At Home COVID-19 Test Kit
• Version Model Number: 20452
• Catalog Number: 289586
• Company DUNS: 117359612
• Company Name: DIAGNOSTIC HYBRIDS, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428101735 [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: 2025-08-18
• Device Publish Date: 2025-08-08

On-Brand Devices [CVS Health At Home COVID-19 Test Kit]

• 30014613340188: QuickVue COVID-19 Test
• 00050428101735: CVS Health At Home COVID-19 Test Kit