BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OSOM BV Blue Control Kit

    DI: 00742860100062 · Model: 184 · SEKISUI DIAGNOSTICS, LLC
    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
    OSOM BV Blue Control Kit
    Primary DI
    00742860100062
    Version / Model
    184
    Catalog Number
    184
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-29
    Public Version
    1
    Public Version Date
    2026-01-06
    Public Version Status
    New
    Public Device Record Key
    71ef780d-7fb2-42aa-93dd-7311ee9e8d6e

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    JTR Kit, Quality Control For Culture Media

    GMDN Terms

    Code Name
    48210 Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00742860100062