BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmuView COVID-19 Antigen Home Test

    DI: 00855402007979 · Model: R0182CHT-20T · CTK BIOTECH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImmuView COVID-19 Antigen Home Test
    Primary DI
    00855402007979
    Version / Model
    R0182CHT-20T
    Catalog Number
    R0182CHT
    Company Name
    CTK BIOTECH INC.
    Labeler DUNS
    081099976
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-08
    Public Version
    1
    Public Version Date
    2023-06-16
    Public Version Status
    New
    Public Device Record Key
    05465e39-c725-4159-99b5-a09a0f617b43

    Device Description

    The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QKP Coronavirus Antigen Detection Test System.

    GMDN Terms

    Code Name
    65454 SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

    Identifiers

    Type ID
    Primary 00855402007979

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius