MMRV IgG Calibrator Set


Product Overview

MMRV IgG Calibrator Set
BioPlex 2200 - 6632400


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 0.5 Milliliter
  • 3 Vials
    • Total Volume: 0.5 Milliliter
    • 3 Vials


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LFY

    Device Name: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

    Device Class: 2

    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: 866.3900

    Third Party Flag: Y

    Medical Specialty: MI


    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


    Code: OPL

    Device Name: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

    Device Class: 2

    Physical State: The device is a fully automated instrument

    Definition: The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or is intended to be affected by the device

    Regulation Number: 866.3510

    Third Party Flag: Y

    Medical Specialty: MI


    Code: LJY

    Device Name: Enzyme Linked Immunoabsorbent Assay, Mumps Virus

    Device Class: 1

    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: 866.3380

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00847865000727

    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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