BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA Centaur TNIH 100T Kit

    DI: 00630414602912 · Model: 10994774 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADVIA Centaur TNIH 100T Kit
    Primary DI
    00630414602912
    Version / Model
    10994774
    Catalog Number
    10994774
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-10
    Public Version
    4
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    3d8ac5f1-a6f2-430e-b331-8fb7955d876d

    Device Description

    ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 100T

    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
    MMI IMMUNOASSAY METHOD, TROPONIN SUBUNIT

    GMDN Terms

    Code Name
    60780 Troponin I IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414602912

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K171274 000

    Storage Conditions

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