This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces


Product Overview

This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces
Entamoeba histolytica Ag (stool) ELISA - EIA-3473


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.


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: GMO

    Device Name: Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: MI

    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: 866.3220

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00840239034731

    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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