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Ceruloplasmin

FDA UDI

Class II (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name
Ceruloplasmin FDA UDI
Generic Name
Ceruloplasmin IVD, reagent FDA UDI
Device Name
The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use. FDA UDI
Model / Reference
11065N FDA UDI
Description
The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
11065N FDA UDI
Primary DI / UDI-DI
08058056680730 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

Yes

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sentinel Ch. Srl

Sources (1)

  • FDA UDI 523b8417-5049-468b-909d-f0ccb1c61475 37 fields · synced May 31, 2026