STELLUX® Chemi Human C-peptide ELISA

Basic Information

• Brand Name: STELLUX® Chemi Human C-peptide ELISA
• Primary DI: B24280CPTHUCH010
• Version / Model: 80-CPTHU-CH01
• Catalog Number: 80-CPTHU-CH01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 1
• Public Version Date: 2020-07-27
• Public Version Status: New
• Public Device Record Key: d800a8e3-272c-49e8-87ad-716f5be0a0b5

Device Description

The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use.

Device Characteristics

• Single Use: Yes
• 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
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	862.1135	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54130	C-peptide IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B24280CPTHUCH010	HIBCC

Customer Contacts

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

Storage Conditions

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