Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis.


Product Overview

Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis.
Pointe Scientific, Inc. Lipoprotein (a) - L7597-CAL


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.


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: DFC

    Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5600

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00811727011831

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos