Identity
- Trade Name
- BinaxNOW RSV FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens. FDA UDI
- Model / Reference
- 430-022 FDA UDI
- Description
- A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011177 FDA UDI
- 510(k) Number
- K032166 FDA UDI
- FDA Product Code
- GQG FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 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: Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
BinaxNOW RSV by Alere Scarborough, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical.
- BD Veritor™ System For Rapid Detection of RSV - Laboratory kit — BECTON DICKINSON AND COMPANY · Class I
- Nano-Check RSV Test — Nano-Ditech Corporation · Class I
- QuickVue — Quidel Corp. · Class I
- BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit — BECTON DICKINSON AND COMPANY · Class I
- QuickVue — Quidel Corp. · Class I
- Sofia — Quidel Corp. · Class I
- OSOM RSV Test Home — Sekisui Diagnostics, LLC · Class I
- Sure-Vue RSV Test — SA SCIENTIFIC, LTD
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 I | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 4b3d0f1e-e625-4ddd-b981-dd60b5904ed2 34 fields · synced May 30, 2026