BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AZURE BIOTECH INC

    Reg #: 3014862351 · FEI: 3014862351 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AZURE BIOTECH INC
    Registration Number
    3014862351
    FEI Number
    3014862351
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10400 Main Street
    City
    Houston
    State
    TX
    ZIP
    77025
    Country
    US

    Owner / Operator

    Firm Name
    Azure Biotech Inc
    Operator Number
    10058544
    Address
    10400 Main Street
    City
    Houston
    State
    TX
    Postal Code
    77025
    Country
    US
    Correspondent
    Frank Luo

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    Fastep COVID-19 Antigen Home Test Fastep COVID-19 Antigen Pen Home Test Fastep COVID-19 IgG/IgM Rapid Test Device COVID-19 IgG/IgM Rapid Test Device Ecotest COVID-19 IgG/IgM Rapid Test Device Diasure COVID-19 IgG/IgM Rapid Test Device COVID-19 IgG/IgM Rapid Test cassette

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device