BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IMMULITE®/IMMULITE® 1000 Systems PAP

    DI: 00630414964355 · Model: 10380953 · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    IMMULITE®/IMMULITE® 1000 Systems PAP
    Primary DI
    00630414964355
    Version / Model
    10380953
    Catalog Number
    LKPA1
    Company Name
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    Labeler DUNS
    296822794
    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
    2025-10-16
    Public Version Status
    Update
    Public Device Record Key
    2e710f09-1ec1-4393-aae4-3c35b8ca510d
    Distribution End Date
    2025-09-30

    Device Description

    PAP - IMMULITE - RGT - 100 Tests

    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
    JFH Acid phosphatase (prostatic), tartrate inhibited

    GMDN Terms

    Code Name
    52907 Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414964355

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K931701 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius