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

    SCoV-2 Ag Detect Rapid Test

    K Number: K233358 · Decision Aug 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    329

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    Basic Information

    Device Name
    SCoV-2 Ag Detect Rapid Test
    K Number
    K233358
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3982
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    InBios International, Inc.
    Date Received
    September 29, 2023
    Decision Date
    August 23, 2024
    Product Code
    QVF
    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
    QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

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