CVS Health At Home COVID-19 Test Kit 289586

GUDID 30014613340188

QuickVue COVID-19 Test

DIAGNOSTIC HYBRIDS, INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 30014613340188
• NIH Device Record Key: 0ac9cba0-4b64-48a5-8f0f-e7fda5dc4296
• 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: true
• 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

Customer Support Contacts

• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidelortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613340188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231795

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: 2024-11-28
• Device Publish Date: 2024-11-20

Devices Manufactured by DIAGNOSTIC HYBRIDS, INC.

• 30014613340188 - CVS Health At Home COVID-19 Test Kit: 2024-11-28QuickVue COVID-19 Test
• 30014613340188 - CVS Health At Home COVID-19 Test Kit: 2024-11-28 QuickVue COVID-19 Test
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• 30014613340485 - Savanna: 2024-05-08 Savanna HSV 1+2/VZV Control Set
• 30014613340492 - Savanna: 2024-05-08 Savanna HSV 1+2/VZV Control Set
• 30014613330486 - D3: 2023-07-18 Normal Mouse Gamma Globulin DFA Reagent
• 30014613339090 - Lyra: 2021-02-25 Lyra SARS-CoV-2 Assay