BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    96A Automated Viral RNA Isolation Kit

    DI: 06973685471028 · Model: 96 Tests · 3D Biomedicine Science & Technology Co., Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    96A Automated Viral RNA Isolation Kit
    Primary DI
    06973685471028
    Version / Model
    96 Tests
    Catalog Number
    3000000000012
    Company Name
    3D Biomedicine Science & Technology Co., Limited
    Labeler DUNS
    561011079
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-27
    Public Version
    1
    Public Version Date
    2021-10-05
    Public Version Status
    New
    Public Device Record Key
    91910c92-7fd7-4c11-8f05-ff926d17f0ee

    Device Description

    The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    JJH Clinical Sample Concentrator

    GMDN Terms

    Code Name
    52521 Nucleic acid extraction/isolation kit IVD

    Identifiers

    Type ID
    Primary 06973685471028