BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimension® clinical chemistry system TPSA Flex® reagent cartridge

    DI: 00842768013874 · Model: 10444889 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Basic Information

    Brand Name
    Dimension® clinical chemistry system TPSA Flex® reagent cartridge
    Primary DI
    00842768013874
    Version / Model
    10444889
    Catalog Number
    RF451
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    005088112
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    8
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    eaf81e21-3e8e-455f-b709-738d6f713875

    Device Description

    Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test

    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
    54664 Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00842768013874
    Unit of Use 00630414601762

    Customer Contacts

    Phone
    +1(800)441-9250
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P000021 001
    P000021 002
    P000021 003
    P000021 004
    P000021 006
    P000021 010
    P000021 012
    P000021 014
    P000021 015
    P000021 017
    P000021 019
    P000021 023

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius