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510(k) Data Aggregation

    K Number
    K251916

    Validate with FDA (Live)

    Device Name
    GenBody COVID-19 Ag Home Test
    Manufacturer
    Genbody.Inc.
    Date Cleared
    2026-03-13

    (263 days)

    Product Code
    QYT
    Regulation Number
    866.3984
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    2 - 120
    Reference & Predicate Devices
    K240728
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GenBody COVID-19 Ag Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

    All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.

    Positive results do not rule out co-infection with other respiratory pathogens.

    This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

    The performance characteristics for SARS-CoV-2 were established from March 2024 to January 2026, when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

    Device Description

    The GenBody COVID-19 Ag Home Test is a manually performed and visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 when tested at least twice over three (3) days with at least 48 hours between tests. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged two (2) years or older.

    AI/ML Overview

    N/A

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