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    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMULITE® Systems TSH Calibration Verification Material TSH

    DI: 00630414979458 · Model: 10388157 · 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® Systems TSH Calibration Verification Material TSH
    Primary DI
    00630414979458
    Version / Model
    10388157
    Catalog Number
    LTSCVM
    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
    2016-09-24
    Public Version
    5
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    ba005d63-54ee-4d3d-afec-3f4d36caa130

    Device Description

    TSH CVM - IMMULITE - CONS

    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
    JLW RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

    GMDN Terms

    Code Name
    38271 Thyroid stimulating hormone (TSH) IVD, control

    Identifiers

    Type ID
    Primary 00630414979458

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K910981 000

    Storage Conditions

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