BEUDAMED
    Product Code: QYT FDA class 2 21 CFR 866.3984

    Over-The-Counter Covid-19 Antigen Test

    Microbiology

    The over-the-counter COVID-19 antigen test (product code QYT) is a Class 2 Microbiology in vitro diagnostic device (regulation 866.3984) intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older. It requires 510(k) clearance and is designed for non-prescription consumer use. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    14
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    13
    Years Active
    3

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    Basic Information

    Product Code
    QYT
    Device Class
    FDA class 2
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 14 510(k) clearances via K numbers.

    K Number Device Name
    K260754 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
    K260095 Heal-Check Rapid COVID-19 Antigen Self-Test
    K251916 GenBody COVID-19 Ag Home Test
    K251595 COVID-19 Detect Rapid Self -Test
    K251753 GenaCheck COVID-19 Rapid Self-Test
    K241313 OHC COVID-19 Antigen Self Test
    K243518 BinaxNOW™ COVID-19 Antigen Self Test
    K241915 CareSuperb™ COVID-19 Antigen Home Test
    K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
    K240728 CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
    K233842 iHealth COVID-19 Antigen Rapid Test
    K233373 Flowflex® Plus COVID-19 Home Test
    K231795 QuickVue COVID-19 Test
    K230828 Flowflex COVID-19 Antigen Home Test

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.