Mercodia Lp(a) ELISA

Basic Information

• Brand Name: Mercodia Lp(a) ELISA
• Primary DI: 07350108630016
• Version / Model: 10-1106-01
• Catalog Number: 10-1106-01
• Company Name: Mercodia AB
• Labeler DUNS: 354553091
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-08
• Public Version: 1
• Public Version Date: 2020-04-16
• Public Version Status: New
• Public Device Record Key: 98e9d6f4-5318-486e-89b0-d1110e7ab188

Device Description

Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MSJ	Apolipoproteins	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64682	Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A, also known as Lp(a) lipid, in a clinical specimen using an enzyme immunoassay (EIA) method. Lp(a) levels are typically used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350108630016	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius