BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys Prolactin II

    DI: 07613336218426 · Model: 09755764190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Elecsys Prolactin II
    Primary DI
    07613336218426
    Version / Model
    09755764190
    Catalog Number
    09755764190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-08
    Public Version
    2
    Public Version Date
    2026-02-23
    Public Version Status
    Update
    Public Device Record Key
    9be1d513-b135-48f7-bad3-2c02bf7c02c8

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    CFT RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

    GMDN Terms

    Code Name
    54335 Prolactin IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 07613336218426

    Premarket Submissions

    Submission Number Supplement Number
    K964748 000