BEUDAMED
    Product Code: MLH FDA class 2 21 CFR 866.5510

    Strip, Hama Igg, Elisa, In Vitro Test System

    Immunology

    The HAMA IgG ELISA In Vitro Test System Strip is a diagnostic assay used to detect human anti-mouse antibodies (HAMA) of the IgG class in patient serum, which can interfere with immunoassay results and cause false positive or negative readings in tests that use murine antibody components. Classified as a Class 2 device under 21 CFR 866.5510 within the Immunology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MLH
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    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.