Pointe autoHDL Reagent packaged for use on the BS480 Analyzer. 4x57mL, 4x18mL Kit. For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only.


Product Overview

Pointe autoHDL Reagent packaged for use on the BS480 Analyzer. 4x57mL, 4x18mL Kit. For the quantitative determination high
Pointe autoHDL for the BS480 - 14-H7545-300


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • 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: 00811727015860

    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


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