N-geneous LDL Cholesterol Reagent (R1)

Product Overview

N-geneous LDL Cholesterol Reagent (R1) - 80-4604-00

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LBR

Device Name: Ldl & Vldl Precipitation, Hdl

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: 862.1475

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 00628063400690

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

Educational Resources