Identity
- Trade Name
- RANSEL CALIBRATOR (RANSEL CAL) FDA UDI
- Generic Name
- Glutathione peroxidase IVD, calibrator FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. FDA UDI
- Model / Reference
- SC10154 FDA UDI
- Description
- This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. FDA UDI
Identifiers
- Catalog Number
- SC10154 FDA UDI
- Primary DI / UDI-DI
- 05055273214550 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Glutathione peroxidase IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glutathione peroxidase IVD, calibrator
Ransel Calibrator (ransel Cal) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI aa007070-46fc-435f-b797-b22e217b3e2b 35 fields · synced May 31, 2026