BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Fungal Serology

    DI: 10634853000213 · Model: 200185 · MICROBIOLOGICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fungal Serology
    Primary DI
    10634853000213
    Version / Model
    200185
    Catalog Number
    200185
    Company Name
    MICROBIOLOGICS INC.
    Labeler DUNS
    060467826
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-26
    Public Version
    2
    Public Version Date
    2024-02-09
    Public Version Status
    Update
    Public Device Record Key
    df06f598-c84a-4e10-8697-8256fb2b30eb
    Distribution End Date
    2023-11-30

    Device Description

    Candida Antiserum, 2mL

    Device Characteristics

    Single Use
    Yes
    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
    LSG CANDIDA SPECIES, ANTIBODY DETECTION

    GMDN Terms

    Code Name
    52038 Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

    Identifiers

    Type ID
    Primary 10634853000213

    Customer Contacts

    Phone
    +1(320)253-7400
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – -20 Degrees Celsius