BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EliA IgG Calibrators

    DI: 07333066020051 · Model: 83-1000-01 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EliA IgG Calibrators
    Primary DI
    07333066020051
    Version / Model
    83-1000-01
    Catalog Number
    83-1000-01
    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
    2
    Public Version Date
    2023-12-11
    Public Version Status
    Update
    Public Device Record Key
    94a1170d-f36e-439c-9e8a-7cc6b8b9e3b6

    Device Description

    Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method.

    Device Characteristics

    Single Use
    No
    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
    NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 07333066020051

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius