BEUDAMED
    Product Code: QBD FDA class 2 21 CFR 866.2950

    Microbial Nucleic Acid Storage And Stabilization Device

    Microbiology

    The Microbial Nucleic Acid Storage and Stabilization Device (also described as molecular transport media) is intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material, used to preserve specimen integrity during transport to a laboratory. It is classified as a Class 2 device under regulation 866.2950, requiring 510(k) premarket notification, and falls within the Microbiology (MI) medical specialty. The product code is QBD. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    17
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    16
    Years Active
    7

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    Basic Information

    Product Code
    QBD
    Device Class
    FDA class 2
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 17 510(k) clearances via K numbers.

    K Number Device Name
    K242820 Puritan PurSafe Plus Collection and Transport System
    K240797 PPH Saliva Collection Kit
    K222771 Sample Preservative Fluid
    K233324 Molecular Transport Media - MTM
    K221547 InActiv Blue
    K212878 Sample preservation solution
    K231013 DNA/RNA Shield SafeCollect Saliva Collection kit
    K221664 CLEARinse CTS Specimen Collection and Transport System
    K221802 iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
    K223497 Spectrum Saliva Collection Device
    K220059 Biosci™ Inactivated Transport Medium, Biosci™ ITM
    K211675 Dasky Disposable Sampling Tube (Model name: VSM02)
    K212113 MagXtract Collection Tube
    K210440 Disposable Sampler Inactivated Transport Media, Nest ITM
    K202641 DNA/RNA Shield Collection Tube
    K201849 eNAT molecular collection and preservation medium
    DEN170029 PrimeStore MTM

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.