Identity
- Trade Name
- SAS Rota Test FDA UDI
- Generic Name
- Rotavirus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- SAS™ Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only. FDA UDI
- Model / Reference
- 0690205 FDA UDI
- Description
- SAS™ Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000301 FDA UDI
- GMDN Term
- Rotavirus 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: Rotavirus antigen IVD, kit, rapid ICT, clinical
SAS Rota Test by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotavirus antigen IVD, kit, rapid ICT, clinical.
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 2e70591e-f672-4e38-accc-33bacfe5f1ec 33 fields · synced May 30, 2026