K-ASSAY® Liquid Lipid Control

Basic Information

• Brand Name: K-ASSAY® Liquid Lipid Control
• Primary DI: 00816426020931
• Version / Model: K110C-2M
• Catalog Number: K110C-2M
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Labeler DUNS: 197934250
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 7cfea9fd-c869-4918-aac6-fd5e18f8401d
• Distribution End Date: 2021-06-18

Device Description

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.

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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30214	Multiple lipid analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816426020931	GS1

Customer Contacts

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

Storage Conditions

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