BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quality Club EliA Autoimmunity

    DI: 07333066020068 · Model: 83-1006-01 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Quality Club EliA Autoimmunity
    Primary DI
    07333066020068
    Version / Model
    83-1006-01
    Catalog Number
    83-1006-01
    Company Name
    Phadia AB
    Labeler DUNS
    354019424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-25
    Public Version
    1
    Public Version Date
    2019-08-02
    Public Version Status
    New
    Public Device Record Key
    c55be60e-0905-4640-8073-f63754bfec6f

    Device Description

    Contains four different single-use vials with control samples, one vial for each month of a four months period.

    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
    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
    OHQ Multi-analyte controls unassayed

    GMDN Terms

    Code Name
    30506 Plasma protein IVD, control

    Identifiers

    Type ID
    Primary 07333066020068

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius