Ceruloplasmin

Basic Information

• Brand Name: Ceruloplasmin
• Primary DI: 08058056681232
• Version / Model: A26842
• Catalog Number: A26842
• Company Name: SENTINEL CH. SPA
• Labeler DUNS: 429572365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 02d12436-ba30-48b1-bf1a-afdb645e3743

Device Description

The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	866.5210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53634	Ceruloplasmin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ceruloplasmin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058056681232	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K051456	000

Device Sizes

Type	Value	Unit	Text
Total Volume	108	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 2 and 8 degrees Celsius