BEUDAMED
    Product Code: PFT FDA class 1 21 CFR 862.3800

    Reagents For Molecular Diagnostic Test Systems

    Clinical Chemistry

    Reagents for Molecular Diagnostic Test Systems is a kit containing reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in subsequent targeted re-sequencing of sample libraries for use as part of molecular diagnostic test systems. It is an FDA Class 1 device regulated under 21 CFR 862.3800, subject to general controls, within the Clinical Chemistry (CH) specialty. The product code is PFT. User-supplied analyte-specific reagents are required for library preparation targeting specific genomic regions of interest.

    View on FDA
    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PFT
    Device Class
    FDA class 1
    Regulation Number
    862.3800
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

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

    Definition

    A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.

    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
    DEN130042 MISEQDX UNIVERSAL KIT 1.0

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.