Identity
- Trade Name
- WELLlife™ FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox FDA UDI
- Model / Reference
- WV01P0001-5 FDA UDI
- Description
- WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862024685 FDA UDI
- FDA Product Code
- QMN FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- N 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
WELLlife™ by Wondfo Usa Co., Ltd. — Class N — 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
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- 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
- Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/Kit — Xiamen Boson Biotech Co., Ltd. · N
- Hotgen™ COVID-19 Antigen Home Test — Beijing Hotgen Biotech 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 N | Pending data |
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Manufacturer
- Manufacturer
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI a4f72966-0f1a-469a-9f17-d1c608ca2af4 35 fields · synced May 30, 2026