BEUDAMED
    Product Code: PII FDA class 2 21 CFR 866.3960

    Candida Species Nucleic Acid Detection System

    Microbiology

    The Candida Species Nucleic Acid Detection System is a qualitative panel for the direct detection of multiple Candida species in whole blood specimens from patients with symptoms of or medical conditions predisposing them to invasive fungal infections, intended for the presumptive diagnosis of candidemia independent of blood culture. It is an FDA Class 2 device regulated under 21 CFR 866.3960, requiring 510(k) premarket notification, within the Microbiology (MI) specialty. The product code is PII. Concomitant blood cultures are required to recover organisms for susceptibility testing and further identification.

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    510(k)s
    3
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    3
    Years Active
    10

    Basic Information

    Product Code
    PII
    Device Class
    FDA class 2
    Regulation Number
    866.3960
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.

    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
    K234063 T2Candida 1.1 Panel
    K173536 T2Candida 1.1 Panel
    DEN140019 T2CANDIDA AND T2DX INSTRUMENT

    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.