BEUDAMED
    Product Code: DGB FDA class 1 21 CFR 866.5800

    Seminal Fluid, Antigen, Antiserum, Control

    Immunology

    The Seminal Fluid Antigen, Antiserum, and Control is an immunological reagent used in clinical and forensic laboratories to identify seminal fluid or its specific protein components in biological samples. This device is classified as FDA Class 1, the lowest risk designation, subject only to general controls and exempt from premarket notification requirements. It is regulated under 21 CFR 866.5800 within the Immunology specialty.

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    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Basic Information

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

    Device Characteristics

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

    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
    K861773 ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.