"720-540 Mumps IgG Test Kit"


Product Overview

"720
Diamedix - 720-540


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 Measles virus in a clinical specimen, using a complement fixation test (CFT).


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: LJB

    Device Name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

    Device Class: 1

    Physical State: IVD reagent kit

    Definition: The qualitative detection of measles specific IgG antibodies in serum or plasma.

    Submission Type ID: 4

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: antigens and antisera used for the detection of measles antibodies

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Not applicable in vitro use

    Regulation Number: 866.3520

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00817273020303

    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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