BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IDS SARS-COV-2 IgG

    DI: 05060169695962 · Model: IS-ID6502 · IMMUNODIAGNOSTIC SYSTEMS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IDS SARS-COV-2 IgG
    Primary DI
    05060169695962
    Version / Model
    IS-ID6502
    Company Name
    IMMUNODIAGNOSTIC SYSTEMS LIMITED
    Labeler DUNS
    494268600
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-08
    Public Version
    1
    Public Version Date
    2021-03-16
    Public Version Status
    New
    Public Device Record Key
    b5127333-0da8-4d6c-9f2a-3f71964c37fd

    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
    Yes
    Has Serial Number
    No
    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
    QKO Reagent, Coronavirus Serological

    GMDN Terms

    Code Name
    64760 SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 05060169695962

    Customer Contacts

    Phone
    +4401915190664
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store the cartridge and calibrators in an upright position in the dark
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius