BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fastep HCG Rapid Test Cassette

    Reg #: 3030648160 · FEI: 3030648160 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ASSURE TECH LLC
    Registration Number
    3030648160
    FEI Number
    3030648160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1521 Concord Pike Suite 201
    City
    Wilmington
    State
    DE
    ZIP
    19803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250117

    Owner / Operator

    Firm Name
    Assure Tech LLC
    Operator Number
    10090182
    Address
    1521 Concord Pike Suite 201
    City
    Wilmington
    State
    DE
    Postal Code
    19803
    Country
    US
    Correspondent
    Allen Chen

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    Fastep HCG Rapid Test Cassette FaStep Pregnancy Rapid Test Cassette

    Establishment Types

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