BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ViroKey™ SX Virus Total Nucleic Acid Kit

    DI: 08885013958188 · Model: 300677 · VELA OPERATIONS SINGAPORE PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ViroKey™ SX Virus Total Nucleic Acid Kit
    Primary DI
    08885013958188
    Version / Model
    300677
    Catalog Number
    300677
    Company Name
    VELA OPERATIONS SINGAPORE PTE. LTD.
    Labeler DUNS
    595361724
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-29
    Public Version
    1
    Public Version Date
    2020-07-07
    Public Version Status
    New
    Public Device Record Key
    8753ff28-1c60-4697-b69e-ba2ecc7f8356

    Device Description

    The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument.

    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 08885013958188