K-ASSAY® Lp(a) Control

Basic Information

• Brand Name: K-ASSAY® Lp(a) Control
• Primary DI: 00816426020979
• Version / Model: K114C-4M
• Catalog Number: K114C-4M
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Labeler DUNS: 197934250
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: c29e435a-9b57-49f0-a993-515ee73a143e

Device Description

For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].

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
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	866.5600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31523	Total lipoprotein IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total lipoprotein lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816426020979	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023853	000

Storage Conditions

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