Identity
- Trade Name
- BinaxNOW COVID-19/Flu A&B Combo Self Test FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens FDA UDI
- Model / Reference
- 20002051 FDA UDI
- Description
- Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877012054 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
BinaxNOW COVID-19/Flu A&B Combo Self Test by Alere Scarborough, Inc. — 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.
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- WELLlife™ — WONDFO USA CO., LTD. · Class II
- Rapid Response — BTNX Inc · Class II
- GenaCheck® COVID-19/Flu A&B Rapid Self-Test — Genabio Diagnostics Inc. · Class II
- Rapid Response — BTNX Inc · Class II
- 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
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 5856f971-c653-4db3-b69a-19aed7f0b245 33 fields · synced Jun 6, 2026