N-geneous LDL-ST Cholesterol Calibrator

Basic Information

• Brand Name: N-geneous LDL-ST Cholesterol Calibrator
• Primary DI: 00628063400744
• Version / Model: 80-5666-02
• Catalog Number: 80-5666-02
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a8410a49-798d-4838-8bcc-eef41052185c

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: No
• 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
JIS	CALIBRATOR, PRIMARY	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41728	Low density lipoprotein (LDL) cholesterol IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063400744	GS1
Unit of Use	10628063400741	GS1

Premarket Submissions

Submission Number	Supplement Number
K992766	000