Identity
- Trade Name
- BinaxNOW COVID-19 Ag Card FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider. FDA UDI
- Model / Reference
- 195-000 FDA UDI
- Description
- The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011290 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N 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: SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
BinaxNOW COVID-19 Ag Card by Alere Scarborough, Inc. — Class N — 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 N | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI ad68c86c-7580-4445-9604-ad21a7a9a0bf 33 fields · synced May 30, 2026