BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accula SARS CoV-2 Control Kit

    DI: B540COV4100010 · Model: COV4100-1 · MESA BIOTECH, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accula SARS CoV-2 Control Kit
    Primary DI
    B540COV4100010
    Version / Model
    COV4100-1
    Catalog Number
    COV4100-1
    Company Name
    MESA BIOTECH, INC.
    Labeler DUNS
    056865474
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-19
    Public Version
    1
    Public Version Date
    2020-05-27
    Public Version Status
    New
    Public Device Record Key
    42dfd75b-96c6-4dca-8dd9-3eb877bb69a1

    Device Description

    The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula™ SARS-CoV-2 Test. Positive swabs are coated with DNA Based Synthetic Oligo. The High Positive Controls contain a level of oligo sufficient to provide a positive result when used with the Accula SARS-CoV-2 Test. The Low Positive Controls contain a lower level of oligo, near the limit of detection of the test, but is sufficient to provide a positive result when used with the Accula™ SARS-CoV-2 Test. When used for quality control in the Accula SARS-CoV-2 Test, these controls are useful as an aid in verifying test and operator performance.

    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
    64748 SARS-CoV-2 nucleic acid IVD, control

    Identifiers

    Type ID
    Primary B540COV4100010

    Customer Contacts

    Phone
    858-800-4929
    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