BEUDAMED
    Product Code: KSJ FDA class 3

    System, Identification, Hepatitis B Antigen

    Unknown

    This device is a hepatitis B antigen identification system, an in vitro diagnostic system used to detect the presence of hepatitis B surface antigen (HBsAg) in blood or serum, enabling the identification of hepatitis B infection or carrier status for blood safety screening or clinical diagnosis. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA). The product code is KSJ; no regulation number or medical specialty classification is recorded in the FDA database. No special flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

    Research product code KSJ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KSJ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.