BEUDAMED
    Product Code: GTR FDA class 1 21 CFR 866.3720

    Antideoxyribonuclease, Streptococcus Spp.

    Microbiology

    The Antideoxyribonuclease, Streptococcus Spp. is a laboratory reagent used to detect anti-DNase B antibodies in patient serum as evidence of recent streptococcal infection, a test particularly useful for diagnosing post-streptococcal sequelae when ASO titers may be low. It is an FDA Class 1 device, presenting the lowest risk and requiring only general controls with no premarket submission. Regulated under 21 CFR 866.3720 with product code GTR in the Microbiology specialty. No special flags apply to this device.

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

    Basic Information

    Product Code
    GTR
    Device Class
    FDA class 1
    Regulation Number
    866.3720
    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

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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
    K790997 ANTI-DNASE B REAGENT 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.