Identity
- Trade Name
- QuickFinder™ COVID-19/Flu Antigen ProTest FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 25 Test Kit / Box FDA UDI
- Model / Reference
- OI-01SU-CC FDA UDI
- Description
- 25 Test Kit / Box FDA UDI
Identifiers
- Catalog Number
- RCUCC25ENP1 FDA UDI
- Primary DI / UDI-DI
- 08809115900418 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, 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
Yes
FDA UDI
Over-the-Counter
No
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, clinical
QuickFinder™ COVID-19/Flu Antigen ProTest by OSANG HEALTHCARE Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical.
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- BD Veritor™ Plus CLIA-Waived Combo Pack — BECTON DICKINSON AND COMPANY · Class I
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- BD Veritor™ System Laboratory Combo Pack — BECTON DICKINSON AND COMPANY · Class I
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- OSOM Flu SARS-CoV-2 Combo Test — Sekisui Diagnostics, LLC
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 |
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Manufacturer
- Manufacturer
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 94173377-9375-4219-83c6-72a61cb66263 37 fields · synced May 30, 2026