Identity
- Trade Name
- Ceruloplasmin FDA UDI
- Generic Name
- Ceruloplasmin IVD, reagent FDA UDI
- Device Name
- The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- A26842 FDA UDI
- Description
- The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- A26842 FDA UDI
- Primary DI / UDI-DI
- 08058056681232 FDA UDI
- 510(k) Number
- K051456 FDA UDI
- FDA Product Code
- JFR FDA UDI
- GMDN Term
- Ceruloplasmin IVD, reagent 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 108 Milliliter FDA UDI
Category: Ceruloplasmin IVD, reagent
Ceruloplasmin by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceruloplasmin IVD, reagent.
- Ceruloplasmin — Sentinel Ch. Srl · 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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 02d12436-ba30-48b1-bf1a-afdb645e3743 38 fields · synced Jun 8, 2026