Direct Lipid Control Set

Basic Information

• Brand Name: Direct Lipid Control Set
• Primary DI: 00817439020000
• Version / Model: 3000
• Catalog Number: 3000
• Company Name: Medtest Dx, Inc.
• Labeler DUNS: 070371210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 9f8d1c6c-8fd9-4edb-a0f3-2f779aafd142

Device Description

This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml

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	00817439020000	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K022591	000

Storage Conditions

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