BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Wondfo

    DI: 00816862024104 · Model: WE03P0014 · WONDFO USA CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    96

    Basic Information

    Brand Name
    Wondfo
    Primary DI
    00816862024104
    Version / Model
    WE03P0014
    Company Name
    WONDFO USA CO., LTD.
    Labeler DUNS
    849098897
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    96
    Record Status
    Published
    Publish Date
    2023-08-11
    Public Version
    1
    Public Version Date
    2023-08-21
    Public Version Status
    New
    Public Device Record Key
    495b5d65-2d3c-4670-b476-866d29b992a7

    Device Description

    Nucleic Acid Extraction Kit: 96 Tests/Kit (96 Samples per Plate), 1 Sample Plate,3 Prefilled Reagent Plates,1 sealed vial with Proteinase K

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJH Clinical Sample Concentrator

    GMDN Terms

    Code Name
    52521 Nucleic acid extraction/isolation kit IVD

    Identifiers

    Type ID
    Package 10816862024101
    Primary 00816862024104
    Unit of Use 00816862024111

    Customer Contacts

    Phone
    630-468-2272
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius