BEUDAMED
    Product Code: MTP FDA class 3

    Antibody To Htlv-1, Elisa

    Unknown

    An HTLV-1 Antibody ELISA is an enzyme-linked immunosorbent assay in vitro diagnostic device used to detect antibodies against Human T-Lymphotropic Virus Type 1 (HTLV-1) in serum or plasma, used in blood screening and diagnostic evaluation for HTLV-1 infection. It is classified as FDA Class 3, requiring PMA approval, and is designated as life-sustaining, with product code MTP. The device is not an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MTP
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    3

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.