BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GenaCheck Rapid Self-Test Kit for Urinary Tract Infection

    Reg #: 3016609999 · FEI: 3016609999 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GENABIO DIAGNOSTICS INC
    Registration Number
    3016609999
    FEI Number
    3016609999
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    19B Crosby Dr. Ste 220
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231045

    Owner / Operator

    Firm Name
    Genabio Diagnostics Inc.
    Operator Number
    10063095
    Address
    19B Crosby Dr. Ste 220
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    weike mo

    Products

    Device Name Product Code
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT

    Proprietary Names

    GenaCheck Rapid Self-Test Kit for Urinary Tract Infection

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198