Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.


Product Overview

Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.
Lp (a) - LP2757


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Protect from light
  • 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: 05055273209198

    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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