BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOER GenePure Pro Nucleic Acid Purification System

    DI: 06973843220116 · Model: NPA-32E · Hangzhou Bioer Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIOER GenePure Pro Nucleic Acid Purification System
    Primary DI
    06973843220116
    Version / Model
    NPA-32E
    Company Name
    Hangzhou Bioer Technology Co., Ltd.
    Labeler DUNS
    545256935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-11
    Public Version
    1
    Public Version Date
    2023-01-19
    Public Version Status
    New
    Public Device Record Key
    f1eb799d-501d-4469-9583-e3c1e5f6fe0d

    Device Description

    For the detail information, please refer to the IFU.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJH Clinical Sample Concentrator

    GMDN Terms

    Code Name
    60736 Nucleic acid sample preparation instrument IVD

    Identifiers

    Type ID
    Primary 06973843220116