Identity
- Trade Name
- BinaxNOW COVID-19/Flu A&B Controls FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, control 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
- 20002055 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
- 00811877012108 FDA UDI
- FDA Product Code
- SCA FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, control 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-genus respiratory virus antigen IVD, control
BinaxNOW COVID-19/Flu A&B Controls by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 a124c3e4-b238-4391-af5e-715ed4d36f99 33 fields · synced Jun 8, 2026