BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MRDx Test

    Reg #: 3007125666 · FEI: 3007125666 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MOLECULARMD CORPORATION
    Registration Number
    3007125666
    FEI Number
    3007125666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1341 SW Custer Drive
    City
    Portland
    State
    OR
    ZIP
    97219
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173492

    Owner / Operator

    Firm Name
    MolecularMD Corporation, an ICON plc company
    Operator Number
    10056701
    Address
    1341 SW Custer Drive
    City
    Portland
    State
    OR
    Postal Code
    97219
    Country
    US
    Correspondent
    Chad Galderisi

    Products

    Device Name Product Code
    Bcr/Abl1 Monitoring Test OYX

    Proprietary Names

    MRDx Test MRDx BCR-ABL Test MRDx BCR-ABL Test Software

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198