Identity
- Trade Name
- Remel Xpect RSV Control FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, control FDA UDI
- Device Name
- Control kit for Remel Xpect RSV Test. FDA UDI
- Model / Reference
- R246012 FDA UDI
- Description
- Control kit for Remel Xpect RSV Test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000806 FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) 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: Respiratory syncytial virus (RSV) antigen IVD, control
Remel Xpect RSV Control by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2c509666-9e50-45ee-9341-057196747769 33 fields · synced May 30, 2026