BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FilmArray Pneumonia/Pneumoniaplus Control

    Reg #: 3005959679 · FEI: 3005959679 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAINE MOLECULAR QUALITY CONTROLS, INC.
    Registration Number
    3005959679
    FEI Number
    3005959679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23 Mill Brook Rd
    City
    Saco
    State
    ME
    ZIP
    04072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190222

    Owner / Operator

    Firm Name
    MAINE MOLECULAR QUALITY CONTROLS, INC.
    Operator Number
    9081510
    Address
    23 Mill Brook Road, Mill Brook Business Park
    City
    Saco
    State
    ME
    Postal Code
    04072
    Country
    US

    Products

    Device Name Product Code
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN

    Proprietary Names

    FilmArray Pneumonia/Pneumoniaplus Control

    Establishment Types

    Manufacture Medical Device