Lp(a) Control Set

Basic Information

• Brand Name: Lp(a) Control Set
• Primary DI: 08058056681744
• Version / Model: 1152201
• Catalog Number: 1152201
• Company Name: SENTINEL CH. SPA
• Labeler DUNS: 429572365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-15
• Public Version: 1
• Public Version Date: 2024-03-25
• Public Version Status: New
• Public Device Record Key: ffdb0fdd-81b9-4607-b88c-a22db1351750

Device Description

Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, according to the indicated analytical procedure.

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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41418	Lipoprotein A IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058056681744	GS1

Customer Contacts

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

Storage Conditions

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