BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Revogene Check

    DI: 00840733103285 · Model: 610220 · MERIDIAN BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Revogene Check
    Primary DI
    00840733103285
    Version / Model
    610220
    Catalog Number
    610220
    Company Name
    MERIDIAN BIOSCIENCE, INC.
    Labeler DUNS
    092815364
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-27
    Public Version
    2
    Public Version Date
    2025-02-06
    Public Version Status
    Update
    Public Device Record Key
    b8b48498-2d0b-41dc-830a-28fed6ef0a93

    Device Description

    The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    61303 Thermal cycler nucleic acid instrument calibrator/control kit IVD

    Identifiers

    Type ID
    Primary 00840733103285

    Customer Contacts

    Phone
    513-271-3700
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius