Lipid and Glucose Measuring System

Lipid and Glucose Measuring System
LipidPlus® Total Cholesterol Test Strips - MD532

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

• Total Volume: 5 Microliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CHH

Device Name: Enzymatic Esterase--Oxidase, Cholesterol

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: 862.1175

Third Party Flag: N

Medical Specialty: CH

Device Id: 10763924532107

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