BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DASH® Negative Control

    Reg #: 3014515702 · FEI: 3014515702 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nuclein, LLC
    Registration Number
    3014515702
    FEI Number
    3014515702
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8305 Cross Park Dr
    City
    Austin
    State
    TX
    ZIP
    78754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241652

    Owner / Operator

    Firm Name
    Nuclein, LLC
    Operator Number
    10092415
    Address
    8305 Cross Park Drive
    City
    Austin
    State
    TX
    Postal Code
    78754
    Country
    US

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

    Proprietary Names

    DASH® Negative Control DASH® Rapid PCR Instrument DASH® SARS-CoV-2 & Flu A/B Test DASH® SARS-CoV-2 & Flu A B Positive Control

    Establishment Types

    Manufacture Medical Device