Access C-Peptide

Basic Information

• Brand Name: Access C-Peptide
• Primary DI: 15099590733377
• Version / Model: C33451
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-28
• Public Version: 1
• Public Version Date: 2023-08-07
• Public Version Status: New
• Public Device Record Key: 67dd5784-a960-4eb5-9c07-684267a099b8

Device Description

The Access C-Peptide assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of C-Peptide levels in human serum, plasma and urine using the Access Immunoassay Systems as an aid in the diagnosis and treatment of patients suspected of having diabetes or other insulin secretion disorders.

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: Yes
• 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	15099590733377	GS1