BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sentosa SQ 318 Chip Kit (8)

    DI: 08885013956399 · Model: 300300 · VELA OPERATIONS SINGAPORE PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sentosa SQ 318 Chip Kit (8)
    Primary DI
    08885013956399
    Version / Model
    300300
    Catalog Number
    300300
    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
    2020-05-13
    Public Version
    1
    Public Version Date
    2020-05-21
    Public Version Status
    New
    Public Device Record Key
    e6177b87-6e2f-4ed6-84b7-070e3c835295

    Device Description

    The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PFT Reagents For Molecular Diagnostic Test Systems

    GMDN Terms

    Code Name
    62173 Nucleic acid sequencing reagent kit IVD

    Identifiers

    Type ID
    Primary 08885013956399