BEUDAMED
    Product Code: GTA FDA class 1 21 CFR 866.3630

    Antisera, All, Serratia Marcesans

    Microbiology

    The Antisera, All, Serratia Marcescens is a collection of antisera used in laboratory serotyping of Serratia marcescens, a gram-negative opportunistic bacterium associated with hospital-acquired pneumonia, urinary tract infections, and bacteremia. It is an FDA Class 1 device subject to general controls only, with no premarket notification required. The product code is GTA, regulated under 21 CFR 866.3630 in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GTA
    Device Class
    FDA class 1
    Regulation Number
    866.3630
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    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.