BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ADVIA® Chemistry Multi-Drug Urine Controls 1,2

    DI: 00630414550916 · Model: 10282987 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ADVIA® Chemistry Multi-Drug Urine Controls 1,2
    Primary DI
    00630414550916
    Version / Model
    10282987
    Catalog Number
    6520064
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    3
    Public Version Date
    2023-03-16
    Public Version Status
    Update
    Public Device Record Key
    a355553c-aeb4-48dd-a568-2fb859034610
    Distribution End Date
    2023-02-28

    Device Description

    Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL

    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
    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
    CIC CRESOLPHTHALEIN COMPLEXONE, CALCIUM

    GMDN Terms

    Code Name
    30503 Multiple therapeutic drugs/drugs of abuse IVD, control

    Identifiers

    Type ID
    Primary 00630414550916

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K040758 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius