Identity
- Trade Name
- QuickFinder™ COVID-19/Flu Antigen Self Test FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- 5 Test Kit / Box FDA UDI
- Model / Reference
- OI-01SU-CC FDA UDI
- Description
- 5 Test Kit / Box FDA UDI
Identifiers
- Catalog Number
- RCUCC05ENA1 FDA UDI
- Primary DI / UDI-DI
- 08809115900425 FDA UDI
- 510(k) Number
- K243262 FDA UDI
- FDA Product Code
- SCA FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing 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
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: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
QuickFinder™ COVID-19/Flu Antigen Self Test by OSANG HEALTHCARE 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, self-testing.
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc. · Class II
- BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc. · Class II
- BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc. · Class II
- Healgen — Healgen Scientific Limited Liability Company · Class II
- BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc. · Class II
- GenaCheck® COVID-19/Flu A&B Rapid Self-Test — Genabio Diagnostics Inc. · Class II
- WELLlife™ — WONDFO USA CO., LTD. · Class II
Cleared under the same submission
K243262 also covers:
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
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 12d02c4a-cd76-463a-b1e2-4744283ed537 37 fields · synced May 30, 2026