BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Atellica IM CYFRA 21-1

    DI: 00630414291345 · Model: 11354591 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Atellica IM CYFRA 21-1
    Primary DI
    00630414291345
    Version / Model
    11354591
    Catalog Number
    11354591
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-16
    Public Version
    1
    Public Version Date
    2026-04-24
    Public Version Status
    New
    Public Device Record Key
    6bf70cf2-51c5-4830-9993-4c458c444cea

    Device Description

    CYFRA 21-1 (CYFRA) Atellica IM - RGT 100T

    Device Characteristics

    Single Use
    No
    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
    OVK cytokeratin fragments 21-1 eia kit

    GMDN Terms

    Code Name
    54612 Cytokeratin IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414291345

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K250925 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius