BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Simplexa COVID-19 Direct

    K Number: K212147 · Decision Sep 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    14
    Review Days
    431

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    Basic Information

    Device Name
    Simplexa COVID-19 Direct
    K Number
    K212147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diasorin Molecular, LLC
    Date Received
    July 9, 2021
    Decision Date
    September 13, 2022
    Product Code
    QQX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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    Other Clearances by Diasorin Molecular, LLC

    K Number Device Name
    K260333 LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
    K251978 LIAISON NES FLU A/B, RSV & COVID-19
    K252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
    DEN230092 Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
    K220963 Simplexa COVID-19 & Flu A/B Direct
    K202755 Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
    K201505 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
    K192376 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
    K190219 Simplexa VZV Direct, Simplexa VZV Positive Control Pack
    K183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
    Search all 14 clearances from Diasorin Molecular, LLC →