BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lyphochek

    DI: 00847661001676 · Model: 563 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lyphochek
    Primary DI
    00847661001676
    Version / Model
    563
    Catalog Number
    563
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    051624070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-09
    Public Version
    5
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    7f1e48a8-3320-4a40-b8e0-107844580756

    Device Description

    Lyphochek Whole Blood Control Level 3 (A human whole blood assayed control.)

    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
    JJY Multi-analyte controls, all kinds (assayed)

    GMDN Terms

    Code Name
    41932 Folate (vitamin B9) IVD, control
    46895 Lead IVD, control

    Identifiers

    Type ID
    Primary 00847661001676

    Customer Contacts

    Phone
    +1(800)854-6737
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K022041 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius