The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma.


Product Overview

The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma.
LDH - LD2812


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total lactate dehydrogenase (LDH) 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: CFJ

    Device Name: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

    Device Class: 2

    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: 862.1440

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 05055273204100

    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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