BEUDAMED
    Product Code: OPL FDA class 2 21 CFR 866.3510

    Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

    Microbiology

    The Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (product code OPL) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3510 in the Microbiology specialty (MI), cleared via 510(k). It is intended for the qualitative detection of IgG antibodies to measles virus, mumps virus, rubella, and varicella zoster virus (VZV) in human serum or plasma, to aid in assessing a patient's serological immune status; it is not intended for screening blood or plasma donors. The device is eligible for third-party review and is not an implant or life-sustaining device.

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    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    14

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    Basic Information

    Product Code
    OPL
    Device Class
    FDA class 2
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K212769 DYNEX SmartPLEX MMRV IgG Assay Kit
    K111072 BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
    K091616 BIOPLEX 2200 MMRV IGG

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.