BEUDAMED
    Product Code: GSK FDA class 2 21 CFR 866.3280

    Antiserum, Francisella Tularensis

    Microbiology

    The Antiserum, Francisella Tularensis is a laboratory antiserum used in serological assays to detect and confirm the presence of Francisella tularensis, the bacterium causing tularemia. As an FDA Class 2 device, it presents moderate risk and requires 510(k) premarket clearance. Regulated under 21 CFR 866.3280 with product code GSK in the Microbiology specialty. No special flags apply to this device.

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

    Research product code GSK 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
    GSK
    Device Class
    FDA class 2
    Regulation Number
    866.3280
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K952141 SAS FRANCISELLA TULARENSIS ANTISERUM

    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.