BEUDAMED
    Product Code: POC FDA class 2 21 CFR 866.1640

    System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

    Microbiology

    The System, Nucleic Acid Amplification Test, DNA, Antimicrobial Resistance Marker, Direct Specimen (product code POC) is a Class 2 microbiology device that uses nucleic acid amplification technology to detect genetic markers of antimicrobial resistance directly from clinical specimens, regulated under 866.1640. It requires 510(k) clearance and falls within the microbiology medical specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    3
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    POC
    Device Class
    FDA class 2
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

    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
    K190613 BD MAX Check-Points CPO
    K173263 Xpert Carba-R
    K160901 Xpert Carba-R

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.