BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optitrol HEPR-2

    DI: 00850075957002 · Model: SR12057 · Lgc Clinical Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    0
    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
    Optitrol HEPR-2
    Primary DI
    00850075957002
    Version / Model
    SR12057
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-30
    Public Version
    1
    Public Version Date
    2026-02-09
    Public Version Status
    New
    Public Device Record Key
    b8c6e89e-424d-440d-be69-bac1080efcfa

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    42652 Multiple blood-borne virus antigen/antibody IVD, control

    Identifiers

    Type ID
    Primary 00850075957002