Identity
- Trade Name
- SAS RSVAlert FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- SAS™ RSVAlertAlert antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients. The test is for in-vitro diagnostic use only. It is recommended that negative test results be confirmed by cell culture. FDA UDI
- Model / Reference
- 041130 FDA UDI
- Description
- SAS™ RSVAlertAlert antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients. The test is for in-vitro diagnostic use only. It is recommended that negative test results be confirmed by cell culture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000363 FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
SAS RSVAlert by Sa Scientific, Ltd — 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.
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- 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
- BinaxNOW RSV — Alere Scarborough, Inc. · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI 92223f3f-c0df-4bd1-8230-8145677d5295 33 fields · synced May 30, 2026