Plasmaproteins Cal 3x

Basic Information

• Brand Name: Plasmaproteins Cal 3x
• Primary DI: 08058056680532
• Version / Model: 11206D
• Catalog Number: 11206D
• Company Name: SENTINEL CH. SPA
• Labeler DUNS: 429572365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-15
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: 027bfaab-4e25-4447-a058-7cf229071d9f

Device Description

Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests with immunoturbidimetric method. Use the Calibrator according to the indicated analytical procedure. For professional use only. For in vitro diagnostics use

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: Yes
• 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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30505	Plasma protein IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058056680532	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Milliliter

Storage Conditions

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