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

This product is intended for in
Direct Lipid Control L3 - 3003

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJY

Device Name: Multi-Analyte Controls, All Kinds (Assayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 00817439020031

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A