Identity
- Trade Name
- Sure-Vue Rotavirus Controls FDA UDI
- Generic Name
- Rotavirus antigen IVD, control FDA UDI
- Device Name
- Sure-Vue® Rotavirus Controls are controls for use with Sure-Vue® Rota Test kits. These controls are for professional use only. FDA UDI
- Model / Reference
- 069101 FDA UDI
- Description
- Sure-Vue® Rotavirus Controls are controls for use with Sure-Vue® Rota Test kits. These controls are for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000516 FDA UDI
- GMDN Term
- Rotavirus antigen IVD, control 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, control
Sure-Vue Rotavirus Controls by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotavirus antigen IVD, control.
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 dfd49b8a-d101-46d6-a429-bf3d9c5ffcf3 33 fields · synced May 30, 2026