BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OncoMate MSI Dx Interpretive Software

    Reg #: 2134567 · FEI: 3002622561 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Promega Corporation
    Registration Number
    2134567
    FEI Number
    3002622561
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2800 Woods Hollow Road
    City
    Madison
    State
    WI
    ZIP
    53711
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200129

    Owner / Operator

    Firm Name
    Promega Corporation
    Operator Number
    9036108
    Address
    2800 Woods Hollow Road, --
    City
    Madison
    State
    WI
    Postal Code
    53711
    Country
    US

    Products

    Device Name Product Code
    Lynch Syndrome Test System PZJ

    Proprietary Names

    OncoMate MSI Dx Interpretive Software OncoMate MSI Dx Assay Installer OncoMate 5C Matrix Standard OncoMate MSI Dx Analysis System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198