BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    binx io CT/NG Assay and binx io CT/NG System

    Reg #: 3017907743 · FEI: 3017907743 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    BINX HEALTH, LTD.
    Registration Number
    3017907743
    FEI Number
    3017907743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Whitehorse Business Park, Derby Court
    City
    Trowbridge Wiltshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K200533

    Owner / Operator

    Firm Name
    binx health, LTD.
    Operator Number
    10079710
    Address
    Whitehorse Business Park, Derby Court
    City
    Trowbridge
    State
    Wiltshire
    Postal Code
    BA14 OXG
    Country
    GB
    Correspondent
    Suzy Korreck

    US Agent

    Business Name
    binx health
    Contact Name
    Suzy Korreck
    Address
    245 First Street, Riverview II, 18th Floor
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    608 6580811

    Products

    Device Name Product Code
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Dna-Reagents, Neisseria LSL
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    binx io CT/NG Assay and binx io CT/NG System

    Establishment Types

    Manufacture Medical Device