The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein-Barr virus (EBV) in human serum. It is of value in providing supportive information for the diagnosis of active infection with EBV.


Product Overview

The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein
MERIFLUOR EBV VCA IgM IFA - EB150


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.


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: JRY

    Device Name: Antiserum, Fluorescent, Epstein-Barr Virus

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 866.3235

    Third Party Flag: Y

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00840733101946

    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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