BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sentosa SQ HIV-1 Genotyping Assay

    Reg #: 3009694456 · FEI: 3009694456 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VELA DIAGNOSTICS USA, INC
    Registration Number
    3009694456
    FEI Number
    3009694456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    353C Route 46W, Suite 250
    City
    Fairfield
    State
    NJ
    ZIP
    07004
    Country
    US

    Owner / Operator

    Firm Name
    Vela Diagnostics USA, Inc
    Operator Number
    10041686
    Address
    353C US Route 46 West, Suite 250
    City
    Fairfield
    State
    NJ
    Postal Code
    07004
    Country
    US

    Products

    Device Name Product Code
    Hiv-1 Genotyping Assay Using Ngs Technology QIC

    Proprietary Names

    Sentosa SQ HIV-1 Genotyping Assay Sentosa SQ HIV-1 Positive Control Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198