Identity
- Trade Name
- CVS Health At Home COVID-19 Test Kit FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- QuickVue COVID-19 Test FDA UDI
- Model / Reference
- 20452 FDA UDI
- Description
- QuickVue COVID-19 Test FDA UDI
Identifiers
- Catalog Number
- 289586 FDA UDI
- Primary DI / UDI-DI
- 30014613340188 FDA UDI
- 510(k) Number
- K231795 FDA UDI
- FDA Product Code
- QYT FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3984 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CVS Health At Home COVID-19 Test Kit by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing.
- Status™ COVID-19 Antigen Rapid Test for Home Use — PRINCETON BIOMEDITECH CORP. · N
- QuickFinder COVID-19 Antigen Self Test — OSANG HEALTHCARE Co., Ltd.
- WELLlife™ — WONDFO USA CO., LTD. · N
- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- iHealth — IHEALTH LAB INC. · N
- Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit — Xiamen Boson Biotech Co., Ltd. · N
- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- WELLlife™ — WONDFO USA CO., LTD. · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI 0ac9cba0-4b64-48a5-8f0f-e7fda5dc4296 36 fields · synced May 30, 2026