Mercodia Insulin ELISA

Basic Information

• Brand Name: Mercodia Insulin ELISA
• Primary DI: 07350108630023
• Version / Model: 10-1113-01
• Catalog Number: 10-1113-01
• 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: 380ab346-acee-4290-8a87-84095d1eaf80

Device Description

Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin 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
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	862.1405	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54238	Insulin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350108630023	GS1

Customer Contacts

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

Storage Conditions

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