iFlash-C-Peptide

Basic Information

• Brand Name: iFlash-C-Peptide
• Primary DI: 06925912718642
• Version / Model: C86037
• Company Name: Shenzhen YHLO Biotech Co., Ltd.
• Labeler DUNS: 420735989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 1
• Public Version Date: 2022-11-03
• Public Version Status: New
• Public Device Record Key: 02ceed43-dfb1-4040-a7ce-8c9dee02d47e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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	06925912718642	GS1