BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    LiquidQC CoV-2 IgG Control

    DI: 00817238010035 · Model: 91494 · CLINIQA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LiquidQC CoV-2 IgG Control
    Primary DI
    00817238010035
    Version / Model
    91494
    Company Name
    CLINIQA CORPORATION
    Labeler DUNS
    078742335
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    1
    Public Version Date
    2020-10-02
    Public Version Status
    New
    Public Device Record Key
    817fc778-bba2-4327-b5a9-201abb1f5fc6
    Distribution End Date
    2020-09-30

    Device Description

    CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    64788 SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

    Identifiers

    Type ID
    Primary 00817238010035