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QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
- Device Name
- 10 Sets / Box FDA UDI
- Model / Reference
- OI-01SQ-C1 FDA UDI
- Description
- 10 Sets / Box FDA UDI
Identifiers
- Catalog Number
- RCQC110ENA1 FDA UDI
- Primary DI / UDI-DI
- 08809115900401 FDA UDI
- FDA Product Code
- MJZ FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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, control
QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit by OSANG HEALTHCARE Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-genus respiratory virus antigen IVD, control.
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- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
- BinaxNOW COVID-19/Flu A&B Controls — Alere Scarborough, Inc. · Class II
- PathoDX RVP Control Slides — REMEL EUROPE LIMITED · Class I
- D3 Fastpoint — DIAGNOSTIC HYBRIDS, INC. · Class I
- OSOM Flu SARS-CoV-2 Combo Control Kit — Sekisui Diagnostics, LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI ee164606-a5df-4208-85c8-674177f2d1f7 36 fields · synced Jun 8, 2026