BEUDAMED
    Product Code: DFQ FDA class 1 21 CFR 866.5800

    Sperm, Antigen, Antiserum, Control

    Immunology

    The Sperm Antigen, Antiserum, and Control is an immunological reagent used in clinical and forensic laboratory settings to identify the presence of sperm or sperm-associated antigens in biological samples. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls without requiring premarket notification. It is regulated under 21 CFR 866.5800 within the Immunology medical specialty. No special risk flags are associated with this product.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    DFQ
    Device Class
    FDA class 1
    Regulation Number
    866.5800
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.