Identity
- Trade Name
- WELLlife™ FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- WELLlife™ COVID-19 / Influenza A&B Antigen Test Cassette, 5 Tests per Kitbox FDA UDI
- Model / Reference
- WCOVFLU-POC-5 FDA UDI
- Description
- WELLlife™ COVID-19 / Influenza A&B Antigen Test Cassette, 5 Tests per Kitbox FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862027006 FDA UDI
- FDA Product Code
- SCA FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3987 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
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: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
WELLlife™ by Wondfo Usa Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical.
- Nano-Check Influenza+COVID-19 Dual Test — Nano-Ditech Corporation · N
- BD Veritor™ Plus CLIA-Waived Combo Pack — BECTON DICKINSON AND COMPANY · Class I
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- OSOM Flu SARS-CoV-2 Combo Test — Sekisui Diagnostics, LLC
- QuickFinder™ COVID-19/Flu Antigen ProTest — OSANG HEALTHCARE Co., Ltd. · Class II
- BinaxNOW COVID-19/Flu A&B — Alere Scarborough, Inc. · Class II
- WELLlife™ — WONDFO USA CO., LTD. · N
- WELLlife™ — WONDFO USA CO., LTD. · Class II
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
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI 5b9b5214-75dc-4cb3-b7c1-dccdc8416ca8 35 fields · synced May 30, 2026