BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoCAP Specific IgG Calibrators

    DI: 07333066019567 · Model: 10-9305-01 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImmunoCAP Specific IgG Calibrators
    Primary DI
    07333066019567
    Version / Model
    10-9305-01
    Catalog Number
    10-9305-01
    Company Name
    Phadia AB
    Labeler DUNS
    354019424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-26
    Public Version
    1
    Public Version Date
    2019-04-03
    Public Version Status
    New
    Public Device Record Key
    7bd3b7d3-af80-4c53-a4a7-151aec8bb865

    Device Description

    Contains one vial of each Specific IgG Calibrator (Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0, Cal-2.0) to form a complete calibration curve for the ImmunoCAP Specific IgG method.

    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

    Product Codes

    Code Name
    JJY Multi-analyte controls, all kinds (assayed)

    GMDN Terms

    Code Name
    53783 Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07333066019567

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072661 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius