BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA Centaur® PSA

    DI: 00630414202990 · Model: 10310293 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    ADVIA Centaur® PSA
    Primary DI
    00630414202990
    Version / Model
    10310293
    Catalog Number
    118157
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    7
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    93e6f003-0486-4d1d-a15c-290e994e9e46

    Device Description

    Prostate-specific Antigen (PSA) Assay Kit (5-pack) 500T

    Device Characteristics

    Single Use
    Yes
    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
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    GMDN Terms

    Code Name
    54665 Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414202990
    Unit of Use 00630414601731

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P950021 001
    P950021 002
    P950021 003
    P950021 004
    P950021 005
    P950021 006
    P950021 007
    P950021 008
    P950021 009
    P950021 011
    P950021 013
    P950021 018

    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