BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMULITE Systems Unconjugated Estriol (uE3) CVM

    DI: 00630414947921 · Model: 10707265 · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMMULITE Systems Unconjugated Estriol (uE3) CVM
    Primary DI
    00630414947921
    Version / Model
    10707265
    Catalog Number
    LUE3CVM(D)
    Company Name
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
    Labeler DUNS
    296822794
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    2
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    7b699f49-743a-45f8-a0b6-f8692ee05f7c

    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
    JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

    GMDN Terms

    Code Name
    38256 Free estriol (oestriol) IVD, control

    Identifiers

    Type ID
    Primary 00630414947921

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K110061 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store below -20 deg C