BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Proov Confirm

    Reg #: 3013443462 · FEI: 3013443462 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MFB FERTILITY, INC.
    Registration Number
    3013443462
    FEI Number
    3013443462
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5485 Conestoga Ct, STE 210
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191462

    Owner / Operator

    Firm Name
    MFB Fertility, Inc.
    Operator Number
    10054102
    Address
    720 Austin Ave, Suite 100-305
    City
    Erie
    State
    CO
    Postal Code
    80516
    Country
    US
    Correspondent
    Amy Beckley

    Products

    Device Name Product Code
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE

    Proprietary Names

    Proov Confirm Pregnancy Pack Fertility 4-in-1 Kit Proov Complete

    Establishment Types

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