BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RENALYTIXAI

    Reg #: 3018739912 · FEI: 3018739912 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    RENALYTIXAI
    Registration Number
    3018739912
    FEI Number
    3018739912
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    30-02 48th Avenue, Suite 150
    City
    Long Island City
    State
    NY
    ZIP
    11101
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200052

    Owner / Operator

    Firm Name
    Renalytix
    Operator Number
    10081544
    Address
    101 6th Avenue, 3 Fl. Rm 324
    City
    New York
    State
    NY
    Postal Code
    10013
    Country
    US
    Correspondent
    Anna Flynn

    Products

    Device Name Product Code
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Prognostic Test For Assessment Of Chronic Kidney Disease Progression QWZ

    Proprietary Names

    UACR kidneyintelX.dkd Collection Kit KidneyIntelX Collection Kit kidneyintelX.dkd

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device