Mercodia C-peptide ELISA

Basic Information

• Brand Name: Mercodia C-peptide ELISA
• Primary DI: 07350108630085
• Version / Model: 10-1136-01
• Catalog Number: 10-1136-01
• 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: b5c35877-8879-4260-9e39-a79092aa1c3b

Device Description

Mercodia C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine.

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
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	862.1135	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63756	C-peptide IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the evaluation of insulin levels as an aid in the diagnosis of hypoglycaemia and insulinoma.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350108630085	GS1

Customer Contacts

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

Storage Conditions

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