Identity
- Trade Name
- Alere i RSV FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens. FDA UDI
- Model / Reference
- 435-000 FDA UDI
- Description
- A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010118 FDA UDI
- 510(k) Number
- K161375 FDA UDI
- FDA Product Code
- OCC FDA UDIOEM FDA UDIOOI FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI862.2570 FDA UDI
- Commercial Distribution
- Not 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
Alere i RSV by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K161375 also covers:
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 d843c766-8db5-44c6-b292-4de68522a17c 35 fields · synced May 30, 2026