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
- CVS Health At Home COVID-19 Test Kit FDA UDI
- Model / Reference
- 20452 FDA UDI
- Description
- CVS Health At Home COVID-19 Test Kit FDA UDI
Identifiers
- Catalog Number
- 289586 FDA UDI
- Primary DI / UDI-DI
- 00050428101735 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
No
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
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Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing.
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- iHealth — IHEALTH LAB INC. · N
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- 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 |
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Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI 7c996c6f-d721-43d8-9f35-19c7725e43ee 34 fields · synced Jun 1, 2026