BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ADVIA Centaur® PHNB

    DI: 00630414527192 · Model: 10322090 · 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 Centaur® PHNB
    Primary DI
    00630414527192
    Version / Model
    10322090
    Catalog Number
    5190841
    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
    2016-09-24
    Public Version
    6
    Public Version Date
    2024-11-04
    Public Version Status
    Update
    Public Device Record Key
    7601045c-8f2d-45da-a547-998fc4331c18
    Distribution End Date
    2024-04-28

    Device Description

    Phenobarbital - CENTAUR - RGT - 50 tests

    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
    DLZ ENZYME IMMUNOASSAY, PHENOBARBITAL

    GMDN Terms

    Code Name
    60983 Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414527192

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K011303 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store Upright, Protect from Light, Do not freeze, Resuspend.