BEUDAMED
    Product Code: QVB FDA class 2 21 CFR 880.2806

    Biological Sterilization Indicator With Indirect Growth Detection

    General Hospital

    The Biological Sterilization Indicator with Indirect Growth Detection is a device placed with products during sterilization processes to monitor sterilization adequacy, using an indirect method (other than direct detection of microbial growth or growth products) to detect surviving microorganisms and confirm whether sterilization conditions were met. Classified as FDA Class 2 under regulation 880.2806, it requires 510(k) clearance in the General Hospital specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    3
    Years Active
    2

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    Basic Information

    Product Code
    QVB
    Device Class
    FDA class 2
    Regulation Number
    880.2806
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    Definition

    A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K251559 InstaTRU Instant Biological Indicator for Steam (IBI-05)
    K252306 Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)
    DEN220042 Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.