BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Candida albicans IgG ELISA

    DI: 00840239034588 · Model: EIA-3458 · DRG International Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Candida albicans IgG ELISA
    Primary DI
    00840239034588
    Version / Model
    EIA-3458
    Catalog Number
    EIA-3458
    Company Name
    DRG International Inc
    Labeler DUNS
    075150847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-20
    Public Version
    2
    Public Version Date
    2020-03-30
    Public Version Status
    Update
    Public Device Record Key
    b2a9192c-9188-4a25-900c-8e1ab71f5b1e

    Device Description

    The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LSG CANDIDA SPECIES, ANTIBODY DETECTION

    GMDN Terms

    Code Name
    52056 Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840239034588

    Customer Contacts

    Phone
    +1(973)564-7555
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Stop Solution
    Total Volume 30 Milliliter
    Device Size Text, specify Wash Solution
    Device Size Text, specify Enzyme Conjugate
    Device Size Text, specify Sample Diluent
    Total Volume 14 Milliliter
    Total Volume 20 Milliliter
    Device Size Text, specify Substrate Solution
    Device Size Text, specify Positive Control
    Device Size Text, specify Negative Control
    Device Size Text, specify Cut-off Control
    Total Volume 2 Milliliter
    Total Volume 100 Milliliter