BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QBC PARALENS ADVANCE

    Reg #: 3011765035 · FEI: 3011765035 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Drucker Diagnostics, LLC
    Registration Number
    3011765035
    FEI Number
    3011765035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Shady Ln Ste 170
    City
    Philipsburg
    State
    PA
    ZIP
    16866
    Country
    US

    Regulatory Submissions

    510(k) Number
    K891276

    Owner / Operator

    Firm Name
    DRUCKER DIAGNOSTICS
    Operator Number
    9078843
    Address
    200 Shady Lane, Suite 170
    City
    Philipsburg
    State
    PA
    Postal Code
    16866
    Country
    US
    Correspondent
    Stephen Naspinski

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ

    Proprietary Names

    QBC PARALENS ADVANCE QBC MALARIA TEST QBC PARAVIEWER QBC MALARIA SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device