BEUDAMED
    Product Code: SGW FDA class 2 21 CFR 866.3176

    Device To Detect Antibodies To Hepatitis D Virus

    Immunology
    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    SGW
    Device Class
    FDA class 2
    Regulation Number
    866.3176
    Medical Specialty
    Immunology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN250032 LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

    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.