Identity
- Trade Name
- BinaxNOW Influenza A & B Card 2 FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens. FDA UDI
- Model / Reference
- 575-000 FDA UDI
- Description
- A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010972 FDA UDI
- 510(k) Number
- K162642 FDA UDI
- FDA Product Code
- PSZ FDA UDI
- GMDN Term
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3328 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: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
BinaxNOW Influenza A & B Card 2 by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 2297b0b7-eb8c-44ef-95e2-af0496f1af62 34 fields · synced Jun 8, 2026