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    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMULITE®Systems sPS CONTROL Third Generation PSA

    DI: 00630414982281 · Model: 10708295 · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    IMMULITE®Systems sPS CONTROL Third Generation PSA
    Primary DI
    00630414982281
    Version / Model
    10708295
    Catalog Number
    LUPCM(D)
    Company Name
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    Labeler DUNS
    296822794
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    6
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    c4995538-b728-4f90-9f3c-28ec47e00851

    Device Description

    sPS Third Generation PSA Control Module

    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
    MTF Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

    GMDN Terms

    Code Name
    38207 Total prostate specific antigen (tPSA) IVD, control

    Identifiers

    Type ID
    Primary 00630414982281
    Unit of Use 00630414601793

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P930027 004
    P930027 005
    P930027 007
    P930027 008
    P930027 010
    P930027 011

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Protect from Light
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius