BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AmpliTrol

    DI: 00847661002772 · Model: 00126 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AmpliTrol
    Primary DI
    00847661002772
    Version / Model
    00126
    Catalog Number
    00126
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    051624070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-14
    Public Version
    3
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    6e3f039c-3c3c-4b1c-827a-d96bb02f7fab

    Device Description

    AmpliTrol CT/GC (An unassayed C. trachomatis and N. gonorrhoeae nucleic acid 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
    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
    OHQ Multi-analyte controls unassayed

    GMDN Terms

    Code Name
    50411 Multiple-type sexually transmitted pathogen nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00847661002772

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius