BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Silaris RSV Test

    DI: B54010300 · Model: 1030 · MESA BIOTECH, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Silaris RSV Test
    Primary DI
    B54010300
    Version / Model
    1030
    Catalog Number
    1030
    Company Name
    MESA BIOTECH, INC.
    Labeler DUNS
    056865474
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-29
    Public Version
    1
    Public Version Date
    2019-08-06
    Public Version Status
    New
    Public Device Record Key
    db6ff31e-2180-4e11-aae4-e0a1b30c3104

    Device Description

    The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    49506 Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary B54010300

    Customer Contacts

    Phone
    800-332-1042
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 86 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius