Identity
- Trade Name
- CERULOPLASMIN (CPL) FDA UDI
- Generic Name
- Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- CPL4017 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207071 FDA UDI
- FDA Product Code
- DDB FDA UDI
- GMDN Term
- Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5210 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
No
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: Ceruloplasmin IVD, kit, nephelometry/turbidimetry
Ceruloplasmin (cpl) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceruloplasmin IVD, kit, nephelometry/turbidimetry.
- Ceruloplasmin — Roche Diagnostics Corp. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Dimension Vista® Ceruloplasmin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Ceruloplasmin — Roche Diagnostics Corp. · Class II
- Ceruloplasmin — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Tinaquant Ceruloplasmin — Roche Diagnostics Corp. · Class II
- N Antiserum to Human Ceruloplasmin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 f3aa6cdb-c8dc-419e-8fce-144d1f58785f 32 fields · synced May 30, 2026