BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Silaris RSV Control Kit

    DI: B54010290 · Model: 1029 · MESA BIOTECH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Silaris RSV Control Kit
    Primary DI
    B54010290
    Version / Model
    1029
    Catalog Number
    1029
    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
    68e891c1-7374-4098-889a-6b51fbfa8ba6

    Device Description

    The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test

    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

    Product Codes

    Code Name
    OCC Respiratory Virus Panel Nucleic Acid Assay System

    GMDN Terms

    Code Name
    52818 Respiratory syncytial virus (RSV) nucleic acid IVD, control

    Identifiers

    Type ID
    Primary B54010290

    Customer Contacts

    Phone
    800-332-1042
    Email
    [email protected]

    Storage Conditions

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